For Blood / Biologics

• Defining GxP Training/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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• Tissue Tracking Failures and Lessons Learned - Hope for the Future - Allograft tissue tracking failures by health care facilities have occurred when tissue banks have issued recalls. In recent years, the expansion of the Joint Commission’s standards for handling tissue, now located in the Transplant Safety Chapter, is helping to close this gap for facilities under their oversight umbrella but it is ultimately up to each facility to comply with Elements of Performance related to complete tracking. Tissue tracking abilities of free-standing, private facilities, such as a number of outpatient surgery centers and physicians’ offices, remains suspect because no regulatory authority requires them to follow tracking protocols for tissue grafts. Tissue banks have historically offered all end users a way to track to tissue recipients by issuing implant cards/forms with each distributed graft, but the final step of completion and return has experienced only fair compliance. In modern times, what else can be done to close this gap in allograft recipient patient safety? Use of universal machine-readable labels on allograft tissues is a future possibility but may only occur if this desire is real and expectations are voiced appropriately and effectively.
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• Stop the Madness! Process Control for Continual Improvement - It is a dark and stormy night. Your facility is readying for what promises to be a challenging third-party review. You, the Quality Manager, along with your organization's General Manager, are reviewing a variety of the process monitoring data reports to prepare for the upcoming "grilling." One such report provides information regarding response times to the central monitoring alarm system, specifically for the reagent storage refrigerator..
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• Nonconformance Management: Key to FDA and ISO 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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• Quality Basics Simplify Complex Engineering Document Management Challenge - In the spring of 2006, Ray Wilson, an internal business systems analyst for an investor-owned utility company, faced a monumental challenge: how to go about transferring the management of approximately 750,000 documents on paper, Mylar, microfiche, and other media from more than 150 different facilities to one centralized location. Although the scope may have been once-in-a-lifetime, at the heart of the task was a common problem for engineers everywhere-content management for engineering drawings.
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• Quality Risk Management Approach to ISBT Validation - According to the ISBT-Guidelines For Validation of Automated Systems in Blood Establishments (Guidelines) the blood bank is responsible for the regulatory compliance of the automated/computerized systems used at the Facility and MUST have a Quality Management System (QMS). Blood Banking organizations around the world support these guidelines, which prescribe that full validation of the computerized system be required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control).
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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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• 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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• Validation of Off-the-Shelf Software - While there is extensive guidance and documentation available for development and validation of proprietary software, there is relatively little guidance available on validation of commercial off-the-shelf software (OTS). The FDA's guidance document for software development, while somewhat dated (2002), provides some general guidance, including reference to general principles of software development, and references to additional guidance documents for software used in Production and Processes.
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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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• 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, let's 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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• Designing a Learning and Performance Program in Tissue and Organ Banking - Keeping up with training management and additional changes in tissue and organ bank environments is an ongoing process. After all, we who work in these environments know what works well and what doesn't. We know for example that with a field-based staff, classroom training is difficult to pull off. Coordinating with everyone's schedules and working around a case load makes training complex! What we have found is that online learning or on-demand learning does work. It allows all of the staff to access training when and where they need it.
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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? After reading this article, you may also wish to forward it to someone who should probably read this, like maybe...oh, I don't know...your CEO...or ummmm...some other top executive? Directions for how to do so without getting into trouble are at the end of this article.
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• Automating Training Control Processes to Comply with FDA and ISO Requirements - 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 requirement and examines the associated challenges for meeting the requirement and the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking requirements is presented..
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• Better Innovation for Product Development and Process Improvement - What is a problem-solving method based on logic and data, not intuition? What is a problem-solving method that accelerates, broadens, and deepens a project team's ability to creatively solve difficult, pertinent problems? The answer is TRIZ. 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.
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• The Challenges of Change Control - The term "change" is something that we all experience both in life and in our business. While some of us might embrace it and seek the challenges, there are more often those that do not like it and are resistant to the implications that change may have. The big difference between the two attitudes is that in life, we face the change, accept it and move on. We do not formalize the event by a series of documents, reviews, evaluations and approvals. In regulated industries, such as pharmaceuticals, biotechnology, and medical devices, the opposite is required and therein are the challenges.
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• Automating Document Control Processes to Comply with FDA and ISO Requirements - 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. Today's quality management systems provide integrated solutions to handle everything from corrective /preventive actions (CAPA) through change control and training. This article will focus on document control processes within the quality system lifecycle and provide insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with FDA requirements and improve overall profitability.
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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 Changing Face of Biobanks - Biobanking is changing rapidly, and it's in no small part due to the demands of systems biology. While small, university-centered banks have existed for decades, large-scale biobanks - whether tissue repositories or population databases - have recently been implemented all across the world. Many are also adding clinical annotation, genetic data, and increasingly genomic, proteomic, and other 'omics information. Population-wide biobanks exist in Iceland, the UK, Sweden, Canada, Estonia, Latvia, Singapore, and Japan. The UK Biobank is one of the most ambitious of these projects, intending to collect, store, and study the genetic information of 500,000 people with the hope of finding correlations between disease and lifestyle, environment, and genes. In the US, the Utah Population Database is the largest of these types of biobanks, housing data from generations of families for more than 8 million people.
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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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• 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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• The Changing Face of Biobanks - Biobanking is changing rapidly, and it's in no small part due to the demands of systems biology. While small, university-centered banks have existed for decades, large-scale biobanks - whether tissue repositories or population databases - have recently been implemented all across the world. Many are also adding clinical annotation, genetic data, and increasingly genomic, proteomic, and other 'omics information. Population-wide biobanks exist in Iceland, the UK, Sweden, Canada, Estonia, Latvia, Singapore, and Japan. The UK Biobank is one of the most ambitious of these projects, intending to collect, store, and study the genetic information of 500,000 people with the hope of finding correlations between disease and lifestyle, environment, and genes. In the US, the Utah Population Database is the largest of these types of biobanks, housing data from generations of families for more than 8 million people.
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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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• Avoiding the CAPA Calamity - Anyone working in quality management is familiar with references to “Death by CAPA” or “CAPA Kills.” CAPA problems are often caused by employees who have the best intentions but end up killing their companies with an overabundance of CAPA entries. How can you avoid your own CAPA calamity?
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• Increasing Efficiency Through Lean Principles - Lean Manufacturing is an operational strategy oriented toward achieving the shortest possible cycle time by eliminating waste. It is derived from the Toyota Production System and its key is to increase the value-added work by eliminating waste and reducing incidental work.
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• Writing and Maintaining SOPs: Drudgery or Delight? - SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. While this ensures compliance with internal processes it also helps ensure compliance with regulating bodies, such as the FDA.
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• Cells and Tissue Traceability and ISBT 128 - Imagine being in a war zone hospital with hundreds of soldiers streaming in with wounds ranging from minor to catastrophic. Blood and tissue transfusions are necessary but the labels aren't standardized; medical staff members are confused. The danger of providing the wrong product to a patient is very real.
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• Legal Risks Affecting Blood Banks - Blood establishments should make CGMP compliance a top priority because the risks associated with systemic or persistent non-compliance are significant. FDA has an array of options: the agency can subject an establishment to repeated inspections, issue warning letters, seize product and sue for injunctive relief. If an establishment's compliance problems are particularly egregious, there is also the risk of criminal liability.
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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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• The Value of Performing a Good Validation in Transfusion Medicine - The blood establishment bears the responsibility for the regulatory compliance of the automated/computerized systems used. Full validation of the computerized system is required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control). The Quality Risk Management approach to validation advocated by GAMP 5 and ICH Q9, a life cycle approach within the QMS, and the use of risk assessments to define the validation strategy for critical systems is a must before any validation is contemplated.
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• AABB Abstract Submission: Everything You Wanted to Know but Didn't Ask - The AABB Annual Meeting and TXPO, slated for October 24 - 27 in New Orleans, hosts many educational activities. Among these is the Abstract Poster session, an opportunity to share your research with others and possibly obtain preliminary publication for grant and funding purposes.
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• Retraining Employees: When Once is Not Enough - Most supervisors would agree that their staff wants to do a good job and that their employees do their best to meet the demands of the highly regulated blood bank industry. But occasionally management has to deal with employee performance that falls short of expectations. This issue becomes increasingly important if the employee has committed an error more than once, in spite of attempts to correct the problem.
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• Blood Bank ISBT 128 Implementation: A View from the Trenches - My own blood bank's ISBT implementation was not quick or easy. If I could do everything again, I would do things quite differently. Hopefully a review of my own mishaps will help you plan your own ISBT implementation more effectively.
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• A Myriad of Documents - Is there Control? - Document control is an issue for every laboratory. Document control is more than generating good documents; it is the ability to compile, review and evaluate documents that are required to ensure the quality of products and services provided. But how?
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• Conferees Seek Paths to Improving Blood Center IT Systems - Blood community professionals and vendors met with officials from the Food and Drug Administration in a first-of-its-kind conference examining the impact of federal regulations on the development of donor and transfusion information technology (IT) systems. The conference, which was originally budgeted for about 60 attendees, drew 170 registrants and a great deal of interest in the impact of federal regulation on the development of donor and transfusion information technology (IT) systems.
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• U.S. Biovigilance Network: Hemovigilance System - The U.S. Biovigilance Network, the nation's first and only nationwide data collection program for the transfusion and biological therapy communities, is preparing for a January 2009 launch of its pilot. The Network has raised more than $1 million in private donations and has also secured support from hospitals and blood centers across the country. AABB's Director of Data and Special Programs describes why the system is vital to the safety of our nation's blood supply.
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• Health Canada's Progress in Regulating Subsequent Entry Biologics: Draft Guidance Issued in March - With Health Canada's recent publication of its draft guidance entitled, "Information and Submission Requirements for Subsequent Entry Biologics (SEBs)," the agency has initiated its plan to introduce a comprehensive regulatory, legal and scientific framework to approve biologic products that are similar to already approved biologics upon patent expiration.
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• Writing and Enforcing Effective SOPs - There is no document more critical to a health care company's compliance and business success than standard operating procedures (SOPs). SOPs define how an employee performs a process or even her own job. Failure to have well-written and clearly defined SOPs is a compliance risk and a business risk. Yet many companies chance a regulatory rumble because they fail to write accurate SOPs.
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• Choosing the Right Tool for Quality Improvement - The most important question to ask when selecting a quality improvement tool is, "What am I trying to do?" "What is my purpose?" There are five fundamental purposes of an improvement team effort--break down, link together, build up, compare and innovate. For each purpose there are one or two basic tools that make those tasks simple.
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• Blood Substitute's Effectiveness and Safety Addressed In Large Clinical Trial - A predicted shortfall of over 4 million units of blood worldwide is driving the need to develop an alternative to red blood cells. Published in the June edition of the Journal of Trauma®, this study is the first Phase III trial to compare a blood substitute to regular blood and was conducted at 46 sites in the United States, Europe and South Africa.
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• The Buzz on West Nile Virus - Summer's onset brings that familiar buzz of the bug we all love to hate: the mosquito. The itch, the swelling, the unsightly bumps on the skin---not to mention the scratching---are the annoying price we pay for outdoor fun.
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• Tracking Blood Electronically - Blood centers have been using reliable and easy-to-scan barcodes to positively identify and track blood products for decades. Radio Frequency Identification (RFID) technology has been widely used other industries with myriad applications for years. The BloodCenter of Wisconsin in Milwaukee is leading an effort that sets the stage to introduce radio frequency identification (RFID) throughout the complete blood supply chain from donation to patient transfusion.
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• San Antonio Hospital Aims to Perform "Bloodless" Surgeries - Northeast Baptist Hospital in San Antonio, Texas has adopted a perioperative blood management program, aiming to perform 90% of surgeries without blood transfusions. The hospital has received support from the South Texas Blood & Tissue Center, which says bloodless facilities help ease the demand for blood and tissue donations.
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• Tissue Banking: Regulations, Operations and Medical Oversight - Human tissues have been used for transplantation and reconstruction for years. But in many ways, quality systems in good tissue practice (GTP) have only recently been applied. Federal regulations exist but don’t extend into the clinical arena. Medical oversight and compliance with voluntary standards are important to enhance and continue the quality elements in hospital that use tissues for transplantation.
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• Blood Banks Move into the 21st Century with Automation - Technology is moving to the next level in hospital laboratories and blood banks. With the current shortage of qualified medical technologists, hospitals are introducing instrumentation and automation techniques into the blood bank.
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• AABB Soliciting Public Comments - The AABB is soliciting public comments from the industry on the proposed 1st edition of Standards for Molecular Testing Laboratories.
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• Sizing Up Staff Competency - Training entry level employees to become competent in a laboratory or technical environment is expensive and time-consuming. Is there a way to assess how much they learned during training?
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• FDA, Blood Community Representatives Meet to Discuss Priorities - FDA and blood community representatives recently met to discuss topics of mutual concern in the areas of donor and patient safety. FDA guidance documents, pandemic planning activities, activities related to TRALI, biovigilance, availability of tests for donor screening, and implementation of ISBT 128 were discussed.
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• Preparing for Assessment by the European Union (EU) - The U.S. is a major supplier of plasma products; it provides 60 percent of the world’s needs for plasma, both recovered and source. As a major player in the European plasma market, U.S. blood centers must undergo assessment by the European Union (EU). How should a U.S. blood center prepare for a European inspection?
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• Making the Blood Supply Safe also Makes it Expensive - A clean and safe blood supply is vital to the health of our country. Blood banks and transfusion centers are beginning to use electronic document systems to keep this vital fluid clean and safe for use.
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• Electronic Document Systems Becoming Integral to Quality Systems for Blood Banks and Transfusion Centers - A clean and safe blood supply is vital to the health of our country. Blood banks and transfusion centers are beginning to use electronic document systems to keep this vital fluid clean and safe for use.
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• HCT/P Inspections: Most Common Deviations - The FDA issued a total of 36 product recalls of HCT/Ps last year and shut down two tissue-recovery firms because of serious Good Tissue Practice violations.
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• Majority of Biological Product Deviation Reports Related to Post-Donation Information - The FDA received 38,618 biological product deviation (BDP) reports for fiscal year 2006, 72 percent of which stemmed from donor-suitability problems that were not detected during initial donor interview.
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• FDA Guidance Pertaining to Certain HCT/Ps: Three Recommended Actions - Less than a year after the FDA’s new donor screening and testing regulations became effective, there were 77 HCT/P deviations reported. So, it was not much of a surprise that the agency recently issued a guidance pertaining to certain HCT/Ps.
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• Four Things You Need to Know About FDA's Guidance for Tissue Establishments - After the FDA shut down two tissue-recovery firms last year because of serious GTP violations, the agency issued a guidance reminding the industry to comply with the regulation.
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• 21 CFR Part 601 and Accelerated Vaccine Approval: Five Things You Need to Know - 21 CFR Part 601 is the basis for CBER’s authority to grant accelerated vaccine approval. Here are five things you need to know about the program.
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• What To Expect After an FDA Inspection - For those who just survived an FDA inspection, or those preparing for one, the question is: What happens after inspection?
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• Blood Center Accreditation by CAP Can Boost FDA Compliance - What’s CAP accreditation got to do with FDA compliance? Considered one of the strictest standards today for clinical labs, CAP could serve as a shot in the arm for your FDA compliance initiatives.
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