For Pharmaceuticals


  • The EMA Guidance for Process Validation - In February 2012, the Committee for Proprietary Medicinal Products (CPMP) issued the latest version of the new EU Guidance for Process Validation (PV). At the end of October, the opportunity for consultation (comments period) closed, marking the time when the various committees review the comments for inclusion or modification of the document. Sometime in 2013, the formalized document will be issued for use. However, generally, what is presented at this stage is often close to the final version. So a review of the current thinking is very opportune at this time.

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  • Introduction to High Risk Software Automated Testing - In today's world, high risk software applications are managing a majority of clinical trial data collected in the field. In the early 2000s, the clinical trial industry saw a switch from managing the data collection process through manual means to doctors utilizing secure software applications that allow the doctor to enter the data electronically through the use of a computer or mobile device. MasterControl itself is an example of a high risk software system that is utilized within the clinical trial industry, as it is focused on creating and regulating the process by which clinical trial documentation is managed. In this article, applications created by vendors (such as MasterControl) that will be utilized by doctors or other managers in the field to aide and assist in the management of clinical trials will be referred to as eClinical software, while the collective group of software providers comprise the eClinical industry (http://en.wikipedia.org/wiki/EClinical_trial_technology/).

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  • New Report Highlights Need to Reduce R&D Cost - Most pharmaceutical and biotechnology companies already feel the pressure to reduce their R&D costs. A recent report showing a decline in the ROI for R&D among some of the world's biggest companies is not going to ease the pressure.

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  • Transitioning from an FMEA Risk Analysis to a Total Rist Management System - Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team themselves identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk assessment is just a part of the entire picture. Organizations are realizing that a total risk management system must be implemented for their quality system to gain the full advantage. This article will discuss how companies can integrate risk management philosophies and techniques into their quality system processes.

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  • MasterControl Revs Operational Excellence Using Six Sigma - The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

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  • Highlights of the 2012 Revised EU Pharmacovigialnce Regulations - In December 2010, the European Commission (EC) published legislation for implementation in July 2012 that made the most sweeping changes to European pharmacovigilance since 1995. Directive 2001/83/EC, covering non-centrally approved products, was amended by 2010/84/EU, and Regulation EC/726/2004, governing centrally approved products and European Medicines Agency activities, was amended by 1235/2010.

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  • Quality Professionals: How to Increase Your Job Security - The life science industry has not been immune to the global economic downturn, with pharmaceutical companies such as AstraZeneca, Roche, and AMAG Pharmaceuticals recently announcing layoffs. Similarly, medical device companies such as Stryker, Medtronic, and Smith & Nephew have announced job cuts. So, is there such a thing as job security anymore?

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  • The U.S. Biosimilar Pathway Nearly Three Years Later - The statutory pathway for approval of biosimilars in the United States1, established in March 2010 with the enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), represented the culmination of 10 years of stakeholder discussion of scientific and policy issues relevant to these products. Nearly three years after its enactment, however, FDA has not approved any biosimilars, debate about implementation of the statute continues, and many questions remain.

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  • Developing a QMS: Should You Buy or Build? - When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems. Either way, an organization must ask itself: Is it more cost-effective to build a homegrown system or to buy a proven and validated QMS? Which option is cost-effective not just initially but over the long haul?

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  • Corrective Action and Preventive Action: What's the Difference? - This is a common question for many people, both inside and outside of the quality community. It periodically appears every few months in virtual discussion groups and electronic bulletin boards. The question is difficult because the concepts have evolved over several decades, without adequate explanation from the core standards and regulations.

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  • Can You Use Automated Testing Tools as an FDA-Regulated Company? - Software test tools help development and testing teams verify functionality, ensure both the reliability and security of the software they develop, and investigate software bugs. Off-the-shelf tools are available for all stages of software development. Examples include static code analyzers, record and replay, regression testing, and bug tracking. Some software testing tool vendors offer an integrated suite that starts with the gathering of requirements and continues through software development and testing throughout the life of a project, including supporting the live system. Other vendors concentrate on a single part of the application development life cycle, such as just testing.

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  • Five CAPA Tips that Help Ensure Compliance - Having been intimately involved in how the U.S. Food and Drug Administration ("FDA") inspects current Good Manufacturing Practice ("cGMP") requirements for nearly two decades, I find myself repeating certain things to companies. Most often, the issues I repeat relate to Corrective and Preventive Action ("CAPA") systems. CAPA systems are a focal point in FDA inspections precisely because they are the process that manufacturers follow in case something goes wrong. In the same way that a person's character may be understood by trial through adversity, quality system auditors and FDA investigators understand a company's operations through its CAPA system.

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  • How to "Sell" Quality - ASQ CEO Paul Borawski asked us to comment on the question, "How do you 'sell' quality to decision makers?" While everyone theoretically believes in the importance of quality, there are times when the demands of the customer cause the focus to shift to speed and cost. Probably many quality heads of departments have been asked to compromise quality requirements at some point to get product out the door. Others find that they have to "sell" the rationale for their very existence as quality departments, with leaders eager to cut costs on staffing for quality. Why do we need so much money for labor that doesn't make product/service? Why can't we just build quality into what we do, so quality auditors are unnecessary?

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  • Quantifying Quality for GxP Compliance - GxP professionals understand the need for quality and quality systems and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insights on how to quantify quality for the development manufacture, and distribution of health products such as drugs, medical devices, and biologics.

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  • Remote Audit: Out of Sight but Not Out of Mind - In life science and other regulated environments, audit is necessary to comply with regulations and to ensure the quality of products. Regulated companies recognise not only the importance of audit, but the value of frequent audits. However, in these economically challenging times, frequent on-site audits can be costly.

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  • How to Build a Strong Supply Chain Team - In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

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  • FDA Fields Tough Questions About Inspections, Challenges Pharma to Be Open, Honest - Last month in Bethesda, at a conference on the Current Challenges of GMPs, presented by Pharma Conference, Inc., FDA officials took FDA's transparency mandate to new levels, by discussing some of the issues they are seeing at pharmaceutical manufacturing and quality operations. They also addressed some critical questions from industry involving the consistency of field inspections, individual inspector styles, and problems with the review process.

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  • Contract Management: What's Compliance Got to Do with it? - Contracts are typically the purview of the finance and legal departments. But in regulated environments, the regulatory, quality, and other departments might also be involved in the contract management process. Depending on the size of a company, the nature of its business, and the regulations and standards it complies with, an organization may be managing different types of contracts, such as quality agreements, supplier agreements, specifications agreement, services contract, IP licensing contracts, nondisclosure contracts, confidentiality agreements, and co-development and co-marketing agreements.

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  • When Good Teams Go Wrong - How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members? If the answer is yes, fantastic—you're in an elite club! But if your team is like many others, sometimes (or more often than not) you feel "dysfunctional." Not quite working on all cylinders... not cooperating or communicating well... not making decisions that stick. Dealing with power struggles that exhaust and frustrate everyone. Running on empty.

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  • Challenges in Combination Product Regulation - Combination products raise a variety of regulatory challenges. In addition to the unique technological and scientific challenges these products may raise, when drugs and devices, drugs and biologics or devices and biologics are combined to create a new product, consideration must be given to what regulatory requirements will apply to the combination product as a whole. This article explains the key principles and processes established for the assignment, premarket review, and postmarket regulation of combination products in the United States.

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  • 100% Training Complete ≠ 100% Effectively Trained - "Can you run me a training report? I need to know where we stand with our training effectiveness program!" For a training manager, this is a double-edged sword. While it is very encouraging that upper management is taking an interest in the training program, focusing merely on the percentage of completion does not measure training effectiveness. .

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  • Regulations Vary Worldwide but Risk Management is Common Denominator - To compete in today's global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management.

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  • Regulatory Submissions: Filling the Critical Gaps in EDM Systems - It's been said that electronic document management (EDM) systems for the management of submission documents are "a dime a dozen." However not all EDM systems are created equal, at least not when it comes to the management of final submission documents. Many of us are familiar with the standard functionality that most EDM systems provides particularly in the life sciences space such as: document types, taxonomy, version control, lifecycle management, securities, PDF rendering, watermarks, and electronic signatures just to name a few.

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  • Is Quality by Design Just for Big Pharma? - At last count, there have been approximately 35 submissions to FDA's CDER with full QbD packages covering all manufacturing operations. To date a few have been approved, notably Pfizer's own Chantix and Selzentry. In one case, the pre-approval inspection was waived and in the other, the inspection occurred but, as the company noted, there were no observations related to the QbD component of the submission. In both cases the concept of the design space was accepted, allowing the company to operate anywhere within this area without further regulatory approvals. Of course, the internal change control system would be used to assess and judge the change before the change could be implemented. So it appears that drug makers of small molecular weight drugs are off to a strong start, although it has taken quite a number of years to accomplish this.

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  • The Importance of Computer Systems I/Os Accuracy Checks - How many times have we read an observation like this by the U.S. FDA? "Your firm has failed to exercise appropriate controls over computer or related systems to assure that the input to and output from the computer or related systems of formulas, other records, or data, are checked for accuracy [21 CFR 211.68(b)]. For example, your firm's custom software for your Master Batch Production record, referred to as the 'I-131 Database,' has not been validated. This software is responsible for generating the batch production record, performing calculations to produce varying concentrations of drug product, and generating label information for customer vials and lead pigs."

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  • Process Verification vs. Process Validation: What You Need to Know - Process validation officially became part of the FDA's Quality Systems Regulation in 1997. Fifteen years later medical device manufacturers still struggle with determining which processes require validation. The confusion traces back to two words, "fully verified." What does "fully verified" mean? What do I do if I determine that process can't be "fully verified?" And, equally important, what are the FDA's expectations when I can't?

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  • Drug Accountability in Clinical Trials - It's not exciting, it's not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren't pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as number three in a list of top five pitfalls.

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  • Trends in Q1 FDA Warning Letters - If you work in the life science industry, it is always a good habit to periodically check the FDA's website for enforcement actions and warning letters. You can glean important insights from the mistakes and weaknesses of other companies in your industry, maybe even your competitors. You will see what the FDA is emphasizing in inspections, perhaps see some trends.

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  • Surviving the Back Room During an FDA Inspection - During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.

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  • Supplier Quality Agreements: Benefits to You and Your Supplier - Supplier quality assurance (QA) agreements can play a vital role in helping companies not only demonstrate to regulatory agencies that they are properly controlling their suppliers, but also show that they are informed and aware of what their suppliers are doing. Manufacturers of all types of medical devices are responsible for the product they make and sell. However, more and more companies are outsourcing all or part of their manufacturing or other operations. Regulatory and certification agencies are therefore looking to the companies that sell the product to have sufficient knowledge and control over their suppliers to assure that products are safe and meet the claims made for them. This article will discuss why supplier agreements are desirable and sometimes even required, which suppliers should have supplier quality agreements, and what should be contained in those agreements.

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  • How Life Science Companies Can Leverage Mobile Technology - Mobile technology has come a long way. Smartphones and tablets are getting better, smaller, and less expensive. It is no wonder that almost everyone has one. More and more employees use them not just for personal reasons, but to perform some of their work. In many cases, companies are forced to provide IT support for these employees. Those companies find themselves having to catch up with their employees who are leveraging mobile technology.

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  • The "Supply Chain" Patient is Sick: Is There a Cure for the Pharma Supply Chain? - Part II - Well, is there a treatment option for the pharmaceutical supply chain? Yes, I would say there is; and the regulators certainly think so too, having been pressing the industry for nearly 10 years to adopt more modern processes by which to develop, manufacture and supply drugs. Dr Janet Woodcock of FDA, in launching the FDA's modernization initiative in 2002, challenged the industry to create a significantly more efficient and high quality supply chain without extensive regulatory oversight.

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  • Outsourcing Trends for 2012 - Top Services by Customer Segment and the Prevalence of Contracting to Emerging Markets - With the goal of optimizing collaborations in the drug development industry, Nice Insight developed a quarterly survey to measure customer awareness and customer perception across 300+ contract research and manufacturers. Nice Insight's Q4 Pharmaceutical and Biotechnology Outsourcing Survey generated responses from 2,619 outsourcing-facing executives from big pharma (29%), specialty pharma (17%), emerging/niche/start-up pharma (22%), biotechnology (25%), and emerging biotechnology (7%). In addition to creating a research tool that aids sponsors in the outsourcing partner selection process and enabling CROs and CMOs to understand their position within the industry, Nice Insight also garners broad industry trends from its survey data.

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  • Clinical CAPA: CAPA Isn't Just for Manufacturing Anymore - Most of us in the pharmaceutical and biopharmaceutical industry are very familiar with the terms Corrective Action & Preventative Action (CAPA) and commonly associate them exclusively with quality and manufacturing. However, CAPA can be applied to many different business areas within an organization, including clinical research. A CAPA consists of a collection of tasks and actions executed to ensure and sustain quality and compliance in day-to-day processes. In clinical research, noncompliance can be extremely costly both directly and indirectly.

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  • FDA Issues Draft Guidance on Biosimilar Product Development - "When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."

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  • The Odd Couple: Quality vs. Research (R&D) - Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as Clinical and Regulatory Affairs. Technology and processes can play a significant role in defining and meeting compliance requirements, however if the technology is not flexible and configurable it can become difficult to implement one solution for all areas.

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  • The "Supply Chain" Patient is Sick: Is There a Cure for the Pharma Supply Chain? - Part I - The pharmaceutical supply chain has never been in such turmoil and under such a global attack from both governments and regulators. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation. High level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Counterfeiting has become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly the most worrisome factors of all, are the cases in which materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.

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  • FDA Says Part 11 Guidance Remains Status Quo - Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.

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  • The New Life Science Solution and its Implications on Document Management for Pharmaceutical Companies - The European Medicines Agency (EMA) recently announced a new pharmacovigilance legislation, describing how to modernize its pharmacovigilance system, how to improve patient safety and how to supply health information to patients. Considering the consequences on information management and business process, pharmaceutical companies have a very short timeline in which to adapt to and implement the initial phase. The attempt to define and establish the "Identification of Medicinal Product (IDMP)" standard as a global harmonized electronic exchange format seems to be the biggest change in the regulatory registration process today. How agencies and pharmaceutical companies can address this new legislation along with the respective consequences for their data management is described in this article.

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  • What to Expect When They're Inspecting - Part II - The first segment of this series focused on some of the non-traditional variables that can have an effect on any FDA inspection and how to achieve a positive outcome regardless of the inspectional conclusion. That article generated some blog discussion on FDA's objectivity. I wanted to clarify some of those issues. FDA Investigators are trained to be objective in all situations and will approach their inspection in this manner. However, firm management needs to understand that when intentional barriers to an effective inspection are presented or the FDA Investigator is met with a less-than-cooperative attitude, the realistic conclusion is that management is trying to hide objectionable GMP conditions, leaving the Investigator no choice but to be even more thorough to ensure there are no safety or quality risks to the consumer. It isn't that an FDA Investigator is showing bias or being subjective, they're "Investigators" - it's their job to do so.

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  • Annex 11: The EU's New Expectations for Regulated Computerized Systems - In 2011, the European Union (EU) revised its guidance for the life cycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. The guidance, called Annex 11, also was revised in response to an alarming number of problems detected in computerized systems. Annex 11 is one of several guidance documents that supplement the EU's GMP rules (EUDRALEX Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice). It applies to all human and veterinary medicinal products made or sold in the EU.

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  • End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals - In a survey conducted by ChainLink Research, pollsters "found that the vast majority of respondents (nearly 80 percent) do not manage risks beyond their immediate first-tier suppliers. Instead, they rely on their immediate suppliers to manage those risks." With so many well-respected supply chain analysts talking about the importance of developing end-to-end supply chain visibility, 80 percent seems like a big number of non-believers. Perhaps it is the phrase "managing risks" that causes that number to be so high. After all, having supply chain visibility is not exactly the same thing as managing risk. Regardless, I suspect that most supply chain analysts would tell respondents who fall into the 80 percent group that they are being short-sighted. Lora Cecere, for example, believes that companies need to develop "value networks that extend from the customer's customer to the supplier's supplier, and that sense, shape and respond by listening, testing and learning with minimal latency."

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  • Is Your Executive Management Team as Involved with the Quality System as They Should Be? - We've all heard of the recent FDA decisions to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area. While there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems.

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  • Reading the FDA Tea Leaves - As the 21st century continues to drive itself forward, it is becoming clear that the US Food and Drug Administration (FDA) is striving to meet modern challenges. Of especial relevance to executives in industries regulated by the FDA is the immediate impact—for the foreseeable future—of the trends shaping agency action. These actions may include the issuance of guidance documents, inspectional strategies and medicinal product approvals/disapprovals. When considering these potential actions, the business executive has a simple question: Will I, my firm, or our products get caught in the crossfires of change without being prepared?

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  • Annex 11 and 21 CFR Part 11: Comparisons for International Compliance - Part 11 establishes the requirements for the technical and procedural controls that must be met by the regulated user if the regulated user chooses to maintain regulated records electronically. Part 11 was published in March 1997. It is strictly applicable in the US to all FDA program areas. Part 11 is applicable also to manufacturers outside of the US and its territories who wish to gain US FDA market approval. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. For the purpose of this analysis it is required to consider the Part 11 Guideline (2003). This guidance is the one used by the FDA for interpretation and to enforce the Part 11 requirements established in the Part 11 regulation. (See Analysis of Part 11).

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  • What to Expect When They're Inspecting - The next time you attend an industry function like BIO, BioEast, or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. It's more than likely that everybody will describe a different inspection experience and that no two perceptions will be the same.

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  • Four 'Dos and Don'ts' for Handling Warning Signs about an Approved Drug - Faced with bad news about an approved drug (e.g. anything from a rise in reports of adverse reactions among patients to FDA notification that a warning letter is in the mail) pharmaceutical companies naturally tend to focus on the crisis at hand: Can this lucrative product stay on the market, or is a recall inevitable? And if the drug can be saved, what can companies do now to help keep it on the market? Such questions must be asked and answered because according to the trade publication, Gold Sheet, an analysis of FDA data shows that a major recall is more likely than ever. For example, the number of drug recalls rose from 426 in 2008 to 1,742 in 2009. From a strategic standpoint, however, pharmaceutical companies sometimes fail to appreciate just how much their early responses to bad news about a product can shape both regulatory intervention and whether or not a company is or is not metaphorically pilloried in the press and slammed in court.

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  • Good Clinical Practice: From Review to Application - As clinical research professionals, we often hear phrases like, "It's in the regs!" Or, "It's GCP!" At times, it may seem as though by classifying our actions as "GCP," we wave a magic wand that ensures regulatory compliance. But what is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important understand the conceptual framework that supports good clinical practice and be able to apply that understanding in daily research practice.

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  • Transfer Comparability and Co-validation - The USP (United States Pharmacopeia) has proposed a new General Information chapter published in the PF volume 35 (September-October 2009). The USP defines transfer of an analytical procedure as "the documented process that qualifies a laboratory (a receiving unit) to use an analytical test procedure that originates in another laboratory (the transferring unit also named the sending unit) ". The USP details several categories of transfer-comparative testing: co-validation, method verification or revalidation, and transfer waivers. The stimuli article also reviews the procedural elements that are recommended for successful transfer. Of these elements, a preapproved protocol is required. The basic content of the protocol is described as well as the process of reviewing the analytical procedure prior to the transfer. There is also a brief paragraph on the contents of the method transfer report and there is reference to statistical approaches for what USP refers to as statistically similar comparability of comparison of procedures, published in USP PF volume 35. The stimuli to the revision is open for comment and can be found on the USP website. This USP stimuli to the revision provides a good basic structure for the transfer process.

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  • Writing and Enforcing Your SOP for GxP Compliance Success - Part 2 - Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

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  • Preparing for a Safety Inspection - Large and small pharmaceutical companies alike face a growing and complex set of international regulations designed to protect patient safety and ensure Good Pharmacovigilance Practices. Inspectors from FDA and European regulatory authorities are increasing their efforts to verify that companies comply with these regulations. The penalties for non-compliance can be severe, including revoking a product's marketing authorization.

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  • How to Build a Business Case for a Quality Management System - It is impossible for FDA regulated manufacturers to conduct business without paying close attention to regulatory compliance. FDA regulations can introduce increasing complexity into internal business processes, delaying the pace of innovation and new product introduction. And complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. The expense, however, pales in comparison to the potential costs and risks associated with non-compliance.

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  • Writing and Enforcing Your SOPs for GxP Compliance Success - This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly ensuring compliance with FDA requirements. Typical definitions include the "procedures" and processes that you use and "operate" under that have been "standardized" to ensure they are done the same way each time. A "clearly written description of how specific tasks are to be done." Or, another definition is "detailed written instructions to achieve uniformity of the performance of a specific function."

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  • Certification and Advanced Degrees: Are They Worth It? - The value of certification and/or advanced degrees, such as an MBA, often comes into question in the wake of economic downturns. There are two camps on the issue. On the one side you have those who spent time and money earning these achievements and now may be questioning the value of these achievements in light of job loss or, at least, job insecurity. The other camp consists of those who don't have advanced education and wonder if obtaining it would help their job search efforts or career aspirations.

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  • Management Review: Measuring the "Heartbeat" of Your Quality Management System - Management Review is sometimes viewed with some ambiguity because there are so many different ways to conduct planned sessions. Most of the approaches taken by medical device companies to organizing these reviews are (just) compliant and even go so far as to fulfill only the very basic requirements of the required Regulations (21 CFR, Part 820) and Standards (e.g. ISO 13485:2003 and ISO 9001:2000). Being compliant and fulfilling perceived needs is not enough, however. Management Review is commonly driven by the use of various quality tools depending upon the caliber of deliverables that are expected and the sophistication of your planned metrics. The following article is not a primer for management review but does contain experience outputs and top-level guidance from practical approaches to process orientation and communication techniques. This sometimes indescribable information relates to those subtle demands that combine your company's Quality Management System (QMS) with business goals and objectives. You'll find that management reviews commonly have your company's unique "signature" embroidered on the agenda pertaining to the "way" you conduct this highly visible gathering of process owners and management with executive responsibility.

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  • How to Avoid Common IND Submission Pitfalls - An Investigational New Drug Application (IND) is like an orchestra - it brings together many players with different specialties that need to work together in harmony to create a synchronous melody (in the case of the orchestra) or message about the compound (in the case of an IND). With one instrument out of tune or with one musician who does not play his or her part there will most certainly be a displeasing sound to the ear and a composition that is thrown off. The same can be said for a section of the IND that does not support the safety of the compound. Keeping the instruments tuned and working together in harmony is comparable to the job of the regulatory group who will, in concert with project management, conduct the IND orchestra. However, keeping everyone in tune, while playing at the same time, and keeping everyone moving toward the same goal of an IND submission can be a challenge with many "sour notes" hit along the way. However, these sour notes can be avoided if everyone is playing the same sheet music and everyone knows how to avoid common INC submission pitfalls.

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  • Developing a Supplier Scorecard: Devising Aspects of Supplier Performance - Organizations have attempted to measure supplier performance in a number of ways as a part of their quality management program, based on customer requests, or part of the effort to manage supply chain risk. Supplier measurement systems have been in place since the mid 1970s with varying degrees of success, both in the product and service industries. Typically, suppliers are provided measures and targets as performance indicators, data is collected on performance and published, and the buyer works with the suppliers to evaluate shortfalls in performance and to develop corrective actions. In some rare cases, the supplier receives incentives and rewards such as being able to provide additional products or services or being designed into future products or services by the buyer. The Balanced Scorecard method has created a significant level of interest and compliance in determining how a specific organization is performing and a supplier measurement system is the underlying way to measure supply chain performance.

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  • Product Risk Management Under ISO 14971:2007 and ICH Q9 - Risk Management has many connotations depending upon the audience. Its definition depends upon whether the context is company disaster recovery, company/product liability, protection of intellectual property, protection of the data processing system and data, and similar. This article covers medical device and pharmaceutical hazard analysis and risk management.

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  • Why Baldrige Works - There's no doubt that the Baldrige Criteria drive excellent performance. Of course, the perennial question for any improvement approach is "What's the return on my investment?" Cargill, a $107 billion company that produces and markets food, agricultural, financial and industrial products and services, says Baldrige is a huge return on investment. Their divisions that use the Criteria achieve 130 percent of their earnings targets versus divisions not using the Criteria, who achieve about 82 percent of target.

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  • Effective Nonconforamnce Management Key to FDA and ISO Compliance - A product's quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved. This is particularly critical in products that have direct impact on public health and safety, such as medicines, medical devices, cars, household appliances, and other consumer goods. For this reason, the proper handling of nonconforming products is incorporated in Food and Drug Administration (FDA) regulations covering drugs, medical devices, and biologics, and ISO international standards, which apply to manufacturers of a wide range of consumer goods.

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  • Seven Signs that Your Quality Program Is in Trouble - Product quality problems don't happen overnight, nor are they the result of a crippled procedure or one poorly conceived policy. The problems have brewed over time, sending out signals that risks to product quality are growing. Because of the unique nature of medical products and the expectations of prescribers and patients, failed product quality translates into a betrayal of trust. It is a safety and brand issue, and problems are on the rise, as evidenced by the 300 percent increase in drug recalls experienced this past year.

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  • Four Common Quality Misconceptions - For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality related issue and are looking to quickly extinguish the fire and prevent recurrences. Or, they may simply want to reduce their overall risks--and costs--by incorporating a specific quality initiative. Every situation is unique, so it's important to be as knowledgeable as possible regarding the company I'm working with and their respective industry. Whether it's a small business owner, a QA Manager, or a CEO of a large corporation, these initial conversations allow me to customize an action plan that will address the client's needs and concerns.

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  • Change Control: Continuous Quality Improvement in FDA and ISO Environments - Globalization of the marketplace has greatly intensified competition. It has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions. The situation could not be more acute than in the FDA and ISO environments, where manufacturers must contend not only with cutthroat competition and a dynamic market, but also stringent regulatory requirements. Consider the fiercely competitive pharmaceutical industry. Only one of every 10,000 potential medicines investigated by American research- based pharmaceutical companies makes it through the rigorous FDA approval process, according to the Pharmaceutical Research and Manufacturers of America. It takes about 15 years at a cost of more than $800 million before a new medicine is approved.

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  • 19 Key Elements to Review for Effective Audits - Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination of business, production, service, and quality factors to provide a holistic impression of the supplier's organization. These factors play a critical role in providing excellent customer service.

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  • Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program - Part 2 - In the previous article I discussed the use of the acronym "GxP" as well as regulations, a changing industry landscape and some suggestions for becoming a learning organization. In this article we will look at learning and why having a strategy, leadership and a comprehensive program is so important in our work and to our future success.

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  • Defining GxP Training and Learning: Part 1 - The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.

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  • Quality Basics Simplify Complex Engineering Document Managmeent Challenge - The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.

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  • Conducting a Clinical Trial in Europe from the Perspective of a U.S. Virtual Company - A common biotech business model is to have a lean and fast virtual organization. These organizations are established with experienced professionals who have a wide breadth of entrepreneurial experience and experience within the pharmaceutical, biotechnology or even medical device sectors. These organizations also have innovative products that are to be developed to the next inflection point, which is usually a step to reduce further developmental risk. The product can then be moved on toward regulatory development or licensed to a larger organization. Conducting early phase I or II (or a combination of both) clinical trials for the innovative product is often the mandate of these types of virtual companies. With limited human resources the organization must outsource many of the tactical and operational activities. For a clinical trial this will include the activities associated with manufacturing, distribution, regulatory, clinical operations, and safety evaluations.

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  • New Commercial Models for New Market Realities - Maximizing the efficiency of commercial operations is standard fare for companies operating in a difficult economy and with budget constraints. Yet, because the pharmaceutical world is moving towards heavier commoditization, with 75-80 percent of mature markets expected to be undifferentiated by 2015, creating commercial efficiencies is no longer simply about managing costs - it's about devising a New Commercial Model (NCM) that better leverages available or yet-to- be-discovered approaches to suit new market realities. This requires fundamental change that ranges anywhere from incremental to substantial.

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  • Automating Training Control Processes for Compliance - FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25) These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This paper identifies the basis for the requirements and examines the associated challenges for meeting those requirements, and in addition, the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking of requirements is presented.

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  • ISO 9001: Quality Objectives and Quality Dreams - This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. The author suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. This article also illustrates ineffectiveness that results from vague and poorly defined quality objectives, and demonstrates how well-structured and documented quality objectives can lead an organization to a more efficient quality management system that increases customer satisfaction. An example of a Quality Objectives Matrix (shown in the paper) presents a useful method for documenting and managing various aspects of quality management systems. The paper will be helpful to those organizations that have not yet formally documented their quality objectives and for those that are interested in improving the effectiveness of their quality management systems and the performance of their business.

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  • Computer System Validation: FDA Inspections - Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. As a result of an increase in federal investigators, investigators are able to inspect more facilities and dig deeper into areas such as Computer System Validation.

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  • Six New FDA Enforcement Policies: How They Impact You - On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA's new enforcement strategy. This strategy involves six new policies that went into effect on September 15, 2009. What are the policies and what do they mean to you? The best line of defense is to have excellent quality oversight now to ensure that the systems in place are compliant, functional, and effective. Then your firm won't have to worry about getting a warning letter in the first place. Easier said than done but more critical now than ever.

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  • Tips for Avoiding Internal and External Supplier Problems - The signing of the historic healthcare reform legislation will have a significant impact on both the medical device and pharmaceutical industries. A significant increase in the number of individuals carrying health insurance will translate into a greater demand for medical devices and pharmaceuticals. While this will improve profitability for many companies, it will present challenges to manufacturing and quality managers tasked with finding ways to quickly increase production.

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  • Quality Audit: A Tool for Continuous Improvement and Compliance - The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store. In this article, we'll systematically take a closer look at some things (e.g, financial statements, a factory process or even customer service) and discuss the results for purposes of evaluation and—ultimately—decision making.

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  • How Will Personalized Medicine Have an Impact on Clinical Trials? - How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharma industry and the patient? Personalised medicine is a current buzz word but what does it actually mean? Some say it has the potential to affect the entire landscape of our healthcare system - over the next ten to 20 years.

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  • Top Five GCP Violations in a Clinical Study - Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, biologics, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The regulations that provide a platform for the quality of the data are Good Clinical Practices or GCPs.

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  • How Auditing Supports Supply Chain Management - One of the fundamental rules of auditing is to measure and evaluate against requirements. While requirements come from multiple sources in an internal and registration audit, for supplier audits these requirements always come from the contract. (Contracts come in a number of different forms, such as purchase orders, letter agreements, etc.) Three things need to be considered, when writing a supplier contract: technical requirements, accept-reject criteria and/or management system requirements.

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  • Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review - What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to have to successfully pass any inspection.

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  • Better Innovation for Product Development and Process Improvement - TRIZ is a problem-solving method based on logic and data, not intuition, which accelerates, broadens, and deepens a project team's ability to creatively solve difficult, pertinent problems. TRIZ provides repeatability, predictability, and reliability due to its structure and algorithmic approach. "TRIZ" is the (Russian) acronym for the "Theory of Inventive Problem Solving." G.S. Altshuller and his colleagues in the former U.S.S.R. developed the basic method between 1946 and 1985, and it has been greatly enhanced by international researchers from 1985 to now. TRIZ is a system of creativity methods that relies on the study of the patterns of problems and solutions—if your end user customer has the problem, we call the solution process "new product/service development" and if you the solution provider have the problem, we call it "process improvement." The same TRIZ process works in both domains. More than three million patents and publications have been analyzed to discover the patterns that predict breakthrough solutions to problems.

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  • Improving Data and Content Migration Testing: A Top Ten for Getting Data and Content Migration Testing on the Right Track - Traditionally, migrations have been tested using some form of post-migration testing, often limited to sampling. While this certainly has a role for some migrations, it starts relatively late in the overall process, is labor intensive, and misses many data-level errors. These limitations come into play particularly in highly regulated companies where the required margins of error are not feasible.

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  • Ten Signs Your CEO Still Has No Idea About ISO 9011 and Lean - It's pretty obvious that in so many companies, based on their actions and behaviors, CEOs and other top managers just don't get ISO 9001 and all the derivative standards. The following 10 signs are written in no particular order. You'll need to be the judge as to which ones are most prevalent within your own organization. How many can you relate to?

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  • Reducing Human Error on the Manufacturing Floor - As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end were human error investigations should begin. Human error is about explaining human behavior. Chemical engineers explain product behavior, mechanical engineers explain equipment behavior, industrial engineers explain process behavior, but who explains human behavior?

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  • Speeding Time To Market For Pharmaceutical & Biotechnology Companies - Pharmaceutical, biotechnology and medical device companies that market blockbuster products can earn over $1 billion dollars per year once their products are approved for sale by the United States Food and Drug Administration (FDA). Approval by the FDA can result in rapid approval to market globally. Companies can invest $1 billion dollars or more over the discovery, research, and development phases of their product candidates. Patent protection can be extended minimally by certain strategies of the developing company. Once patents expire, generic products can enter the market at a fraction of the development cost and reimbursement rates of original products.

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  • Speeding Time To Market For Pharmaceutical & Biotechnology Companies - Pharmaceutical, biotechnology and medical device companies that market blockbuster products can earn over $1 billion dollars per year once their products are approved for sale by the United States Food and Drug Administration (FDA). Approval by the FDA can result in rapid approval to market globally. Companies can invest $1 billion dollars or more over the discovery, research, and development phases of their product candidates. Patent protection can be extended minimally by certain strategies of the developing company. Once patents expire, generic products can enter the market at a fraction of the development cost and reimbursement rates of original products.

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  • From the Project Manager's Toolbox: Strategies for eCTD Marketing Application Submissions - Nothing may invoke fear in the heart of new, or even seasoned, regulatory project managers more than the preparation and submission of a marketing application in eCTD format for their company. At first glance, marketing application submissions can appear to be a tedious effort to manage with hundreds of documents and players, and requires orchestrating intricately detailed timelines and intertwined steps. A successful filing is possible but requires beginning with the end in mind by planning for and organizing the application's contents and process steps and creatively managing timelines to fully utilize existing resources.

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  • Automating Document Control Processes to Comply with FDA and ISO Requirements - The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.

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  • The 5 "W"s of Quality Agreements - Items to address in a Quality Agreement include all aspects of a project that affect the identity, quality, safety, potency, and purity of a product. Additionally, include aspects that may affect the compliance status of either the Contractor or Client. One of the most overlooked sections is the Definitions section - it is critical that everyone knows what is meant by every term used in the Quality Agreement; especially when contracting with non-U.S. parties, terminology can vary widely. Include abbreviations and acronyms, and define documents - one person's batch record is another person's data sheet. Define "subcontracting," and if/when it is acceptable. Also, what NOT to exclude from a Quality Agreement is also worth mentioning.

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  • Things Change - Plan On It - People often bemoan the requirements relating to monitoring and measuring. The general consensus is that it's a good idea to track error and defects, but to monitor that which appears to be running smoothly is a waste of precious resources. Within these tough economic times, that argument can't help but sway managers, unless a compelling counterbalance is offered. Time and again, quality professionals stake their justifications in "ISO says so" rather than in objective indicators.

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  • Data and Content Migrations: Minimizing the Risk - Compliance and business risk plays a significant role in the implementation methodologies of corporate information systems. Further, the compliance and business risks associated with these corporate information systems are, in general, well known. However, as part of the implementation process many of these information systems will be populated with legacy data. The compliance and business risks associated with migrating this legacy data and content into a new system are not necessarily understood. In this context, risks associated with data migrations are a direct result of migration error. Further, industry testing strategies to mitigate such risk, or more specifically data migration error, lack consistency and are far from deterministic. This is the first of two articles that present some thoughts and recommendations on how such a testing strategy can be designed.

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  • The Challenges of Change Control - Maintaining the validated state of equipment, utilities and processes is a basic component of a quality system as defined in current regulations and to that end, changes made to these items need to be documented through a formal change control program. The composition of a change control program can be as different as companies themselves, but the basic expectations of such programs can be summarized.

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  • Please Don't Call Them CAPAs - I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separate processes that have been mashed together resulting in a diminution in the effectiveness of both.

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  • FDA Chooses MasterControl's QMS - MasterControl, a global provider of quality management systems (QMS), is pleased to announce that it has been selected as the QMS software provider for The Food and Drug Administration (FDA). More specifically, The Office of Regulatory Affairs (ORA) within the FDA has contracted with MasterControl through its partner, i4DM. The mission of the Office of Regulatory Affairs is to protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products. ORA's plans to implement MasterControl as its QMS solution throughout all of its various divisions and offices. ORA's field auditors are among those slated to use MasterControl's QMS Software.

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  • Biologic-Device Combination Products: Jurisdiction - More and more companies are developing combination products for many life threatening and unmet medical needs. One area that holds much promise is the development of tissue engineered products which contain living cells or tissues combined with a device. As with any novel technology, questions regarding what the requirements will be by the regulators to obtain market approval is always an issue. This has been a changing dynamic in other parts of the world but the Food and Drug Administration (FDA) has dealt with these products for some time and has developed a reasonable approach to regulating combination products. This article will focus on the FDA approach to jurisdiction of cell and device combination products.

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  • Taming the Regulatory Beast: Role of Regulatory Trend Analysis in Successful FDA Approval - The biggest risk in drug development is failure to convince the FDA that your product meets the requirements for marketing approval. By the time a company files a New Drug Application (NDA), it believes that sufficient evidence is available in support of the marketing approval, based on its understanding of the regulations and requirements. However, about 40% of the NDAs submitted to the FDA are rejected for one or another reason while more than half go through multiple cycles of review adding additional cost and delays to the ultimate approval to market a product.

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  • Avoiding the CAPA Calamity - Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught.

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  • Changing Trends: Clinical Research Personnel Qualifications - In the last decade, clinical researchers have conducted clinical trials where their lack of knowledge of human subject protections embodied in Good Clinical Practices and ethical conduct for research (Belmont Report, Declaration of Helsinki) has resulted in clinical trial misconduct and subject deaths. Notably, these cases were reported in both our news media and professional publications.

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  • Investigator Final Reports: A Tool for FDA Inspection Readiness - What is the best way to prepare for a FDA inspection? Anderson describes ways to make a good first impression on a field investigator using tools available from the FDA.

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  • Status Means More than Prestige in Lifecycle Management - Lifecycles are normal states of nature. Plants, animals, and all manner of things are born, live useful lives and die. Documents have their own lifecycles, passing through different statuses before ending in archives. MasterControl's Lane Hirning explains the different statuses a document goes through and the significance of the document lifecycle for regulatory submissions. Read more.

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  • Why the "Band-Aids" Keep Falling Off - When we cut ourselves, we automatically reach for a Band-Aid®. Why? It stops the bleeding and we can quickly return to whatever we were doing before the accident happened. Root cause fixes can be applied a lot like Band-Aids; a quick solution to stop the bleeding and hope the problem solves itself. When the problem returns again or worsens, we realize that our quick fix might have backfired into something more. Peter Senge, author of "The Fifth Discipline Fieldbook," describes this as "Fixes that Backfire." His model depicts a two-cycle process. The cycle begins at the onset of a problem and we quick-fix (put on a Band-Aid) the problem.

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  • Designing a Winning CAPA System - Various sub-system elements of a Quality System (QS), business and manufacturing processes produce non-conformances. All relevant QS sub-systems must be designed to identify and correct their non-conformances. These QS sub-systems are also expected to operate within a state of "control." These QS sub-systems are unique and separate entities from the CAPA System, which is also a QS sub-system. There is, however, a hierarchical relationship between these QS sub-systems. QS sub-systems that produce non-conformances must have the ability to analyze and appropriately escalate non-conformances that are identified as either "high risk" or are the result of "out of control" process conditions.

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  • FDA's Evolving Civil Money Penalty Authority: Simple Violations Can Lead to Major Costs - The U.S. Food and Drug Administration (FDA) has several enforcement tools at its disposal, including Warning Letters, injunctions, seizures, and criminal prosecutions. While most industry professionals are familiar with these enforcement tools, FDA's civil money penalty (CMP) provisions may be less familiar to some. In the past five years, CMPs have emerged as an important enforcement tool as Congress has increasingly expanded FDA's authority to impose such penalties. With the expansion of FDA's CMP authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the number of CMP cases will likely increase in the coming months and years.

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  • Current Political Climate Favors Passage of Drug and Device Accountability Act of 2009 - Although essentially the same as its 2008 predecessor, the recently announced Drug and Device Accountability Act of 2009 is much more likely to become law in today's more favorable, "accountability-conscious" political climate.

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  • Good and Bad Responses to 483s - Preparing a response to a Form FDA 483 can be a time-consuming and stressful process. It diverts resources from other activities and, if not managed properly, the process can be overwhelming. If a 483 response is well written, factually correct and complete, it will establish that the firm has taken or is in the process of taking appropriate corrective and preventive action. This can allay FDA concerns about the firm's compliance, and reflect positively on the organization. If the response is poorly written, contains errors or omits critical information, it can trigger additional inspections or a Warning Letter. If the firm submits inadequate responses to a Warning Letter, the firm is at risk for seizures, suspension of product approvals, injunctive action or possibly criminal prosecution. While this article is focused on 483 responses, the recommendations apply equally to Warning Letters.

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  • SPL R4: The Latest on Electronic Regulatory Submissions - As of June 1st, 2009 the FDA will no longer accept Establishment Registrations or Product Listings submitted on paper for human prescription drugs, human over-the-counter drugs, or listed biologics and veterinary medicines. After that date, all such filings must be made electronically through the FDA's electronic submission gateway and encoded in XML, according to the rules set out in the HL7 Structured Product Labeling (SPL) standard and the FDA implementation guide. Medical devices are not currently included but are likely to be included in the future.

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  • Value Adds to ISO 9001:2000 Compliance - I've been auditing to ISO 9000 since 1992. A part of my auditing philosophy has been to add value to the audited organizations by suggesting opportunities for improvement. I will describe the most effective "value adds" in this article.

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  • Navigating the FDA's New Requirements for eCTD Submissions - Compliance of electronic documents can be easily and inexpensively achieved through the proper use of Microsoft Word to author documents, combined with the use of templates with electronic submission compliance features built into the template design.

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  • Three Steps to Improved Compliance Management - It's not surprising that pharmaceutical leaders have compliance concerns. If the $875 million fine leveled against TAP Pharmaceuticals back in 2001 didn't open eyes, the public's declining opinion of the drug industry - along with regular headlines about lawsuits, safety problems and generics squabbles - provide regular wake-up calls.

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  • FD&C Amendments at Work in the Pharmaceutical Industry - From 1938 to the present day, the FD&C Act has been amended several times, creating ripples within the pharmaceutical sector. Many of these amendments directly influence the pharmaceutical industry on a daily (or more intermittent) basis.

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  • From Poison Squad to Industry Regulator-- FDA: A Historical Perspective - America's Founding Fathers didn't invent the FDA. The focus on defending the public's health was of little concern until 1820. How did the life science industry go from no regulation to federal oversight in nearly 200 years?

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  • Adverse Event Reports Hit Record High - According to FiercePharma, the number of deaths (4,825) and serious injuries (21,000) associated with prescription drugs during the first quarter of this year was higher than it's ever been. These numbers represent nearly a threefold increase over the previous quarter, and a 38-percent increase over last year's quarterly average.

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  • America Leads the World in Cancer Research Investment - A recent report from the Pharmaceutical Research and Manufacturers of America (PhRMA) says that U.S. pharmaceutical research and biotechnology companies are the primary source of R&D funding for new medicines. Industry-wide spending on research reached a record $58.8 billion in 2007.

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  • Analytical Method Validation: What is Expected? - Improper analytical method testing can yield dire consequences for companies whose laboratories neglect proper validation procedures. FDA warning letters, poor reproducibility and production disruptions are results of organizations that fail to provide assurance that their test methods have been appropriately validated or verified. Industry expert Michele Piepoli discusses requirements and expectations of regulatory bodies regarding the performance and documentation of an analytical method validation.

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  • An Analysis of Heparin, Accountability and Pre-emption Where Are We Now? Part II - The discussion draft of the FDA Globalization Act of 2008 has stimulated a great deal of conversation about ensuring the safety of the U.S. food, drug, medical device and cosmetic supply in the global marketplace. In the second of a two-part series, Christine Humphrey addresses the FDA's inspection initiatives for foreign manufacturers and the agency's stance on pre-emption.

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  • An Analysis of Heparin, Accountability and Pre-emption Where Are We Now? -The "discussion draft" of the FDA Globalization Act of 2008 is the result of a congressional focus on global imports - this proposed Act was triggered by the importation from China of contaminated raw material for heparin. The heparin tragedy was not surprising in light of the Government Accounting Office's (GAO) reports that the FDA has been lacking in its ability to control foreign inspections of both device and drug manufacturers. The most recent GAO reports of late, in 2007 and 2008, demonstrate a continued lack of FDA control over foreign manufacturing operations for nearly 10 years.

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  • Accelerating Submissions Processes with Templates for Microsoft Word® - Is the Common Technical Document new to your company and authors? Are you unsure about what eCTD "granularity" means? Templates optimized for eCTD granularity and for Adobe Acrobat Portable Document Format (PDF) requirements may help you comply with international regulatory guidelines for PDF requirements for eCTD submissions.

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  • Pundits Forecast Pharma's Future - End of first-quarter economic reports are pouring in and the economic pundits are pondering the industry's performance in 2007 and forecasting pharma's future in the remainder of 2008. If blockbuster drugs are a thing of the past, then what's the next big industry moneymaker?

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  • Investigating the Investigators: Another Headache for Drug Sponsors - One leading indicator of a more enforcement-minded approach at the food & drug administration may be a crackdown on clinical trial investigators suspected of fraud. One thing is already clear: sponsors who rely on investigators who trigger suspicions will pay a price in the form of an even tougher time getting the drug through FDA.

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  • Using Good Systems Practice to Right-Size IT Services for Emerging Biotech Firms - Is your biotech’s approach to IT more art than science? Learn some basic best practices that can cut IT costs and institutionalize your company’s knowledge base.

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  • Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Direct Final Rule - At the end of 2007, the FDA announced an amendment to its current GMP regulations for finished pharmaceuticals. Will your organization be affected by this final rule?

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  • Five Essential Elements of Computerized Systems Used in Clinical Trials - Know the critical aspects of electronic systems used in clinical trials.

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  • Find Your Place on the Biotech Maturity Model and Make Better IT Decisions - A three-stage model can help biotech firms determine current and future information technology needs.

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  • Malcolm Bertoni Handles the Heat Electronic Submissions, IT Changes Challenge FDA - Malcolm J. Bertoni is establishing the FDA’s strategic vision for transforming regulatory operations, with its emphasis on the importance of electronic submissions. This is a hot topic for his department and for the life sciences industry.

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  • Speed-to-Market and Accuracy: Challenges of the New Pharmaceutical/Biotech Market - Speed-to-market objectives in pharmaceutical/biotech companies are being redefined in today’s more competitive and stricter regulatory environment.

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  • Selling Biotech Involves Tricky Marketing Calculus - Since health care products arrive slowly into a heavily regulated market, they have to get ready early to hit the market in the right position. That requires advance planning on two fronts, according to Richard Brewer, who led biotech company Scios in Mountain View before Johnson and Johnson acquired it for $2.4 billion in 2003.

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  • FDA Requirement for New Electronic Submissions - One of the main topics discussed at DIA's 43rd annual conference was the FDA's format requirement for new electronic submissions. Read about what was discussed.
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  • In light of a new clinical guidance, a recent survey shows that the FDA is interacting more effectively with the industry - A new clinical guidance from the FDA marks an increased effort towards communication between FDA's regulation enforcement and the industry.
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  • New FDA Guidance Aims to Strike a Balance Between Risks and Benefits of Drugs - The FDA has issued a new guidance that addresses the scarcity of information about the safety of prescription drugs after they are approved.
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  • FDA's Q9 Guidance: Four Key Concepts to Remember - Risk-based management is not just a buzzword. It's here to stay. The FDA recently issued a new guidance on the subject.
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  • FDA Report: Early and Effective Communication Key to First-Cycle Approval - The difference between getting your NDA or BLA approved by the FDA during the first cycle of product review and getting it approved much later may very well lie in how early and how effective you communicate with the agency.
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  • Seven Critical Concepts of the FDA’s Quality Systems Guidance - The FDA recently finalized a guidance to help pharmaceutical companies operate modern quality systems that are fully compliant with CGMPs. The guidance identifies seven concepts critical for modern quality systems.
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  • PDUFA IV: Pros and Cons of the Proposed FDA User Fee Increase - How much is drug safety worth? Priceless. But for the pharmaceutical industry, the price tag is about $392.8 million in annual user fees.
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  • QCU Issues: Top Reason for FDA-483 Citations Among Drug Companies - If you're looking to improve a single area in your FDA compliance program, look no further than your quality control unit.
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