Showing items tagged as Pharma

  • Where Are You in Your Quality Management Maturity?

    31 January, 2014 Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    We’ve all heard about quality management journeys or trips down the quality lane. I heard someone recently equate quality to following the yellow brick road. Quality similes are usually about pathways but this week, I read a new description.

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  • An Argument for Effective Quality Management Systems

    31 December, 2013 Kamaal Anas, Vice President Regulatory Affairs, Wright Medical Technology

    All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.

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  • Biosimilars Establishing Themselves in Europe

    12 December, 2013 Peter Calcott, President, Calcott Consulting LLC.

    From the introduction of the Guidelines for Biosimilars in the EU in 2004, Europe has been pressing hard for the introduction of these money-saving options into the marketplace.  The initial guidelines of 2004 were followed very rapidly with further guidances on comparability (2005), preclinical and clinical requirements (2005), recognition of the changing landscape (2010) and in 2011, further recommendations for studies and statement of the recognition of the issues surrounding lice

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  • A Risk-Based Approach to Validation

    10 December, 2013 Peter Knauer, Partner Consultant, MasterControl Inc.

    FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES) have provided a streamlined risk based approach under an updated life cycle management methodology. Under this scenario, a new definition of validation has emerged, best described by FDA as “the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” This is in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75:

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  • 6 Ways to Leverage Risk-Based Monitoring & Clinical CAPA

    14 November, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    A big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years.  For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).

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  • Avoiding the Silo Effect: The Importance of Communication in Clinical Trials

    12 November, 2013 Rebecca York, Senior Clinical Research Associate, PPD

    As clinical research professionals, we rely on the adage, “If it wasn’t documented, it wasn’t done.” This simple concept guides our every effort in creating solid, reproducible scientific progress. However, without effective communication between stakeholders in clinical trials, research sites are doomed to repeat the same (well-documented) mistakes, and study progress can be hindered, shrouded in a fog of confusion and misunderstanding. With that in mind, perhaps the time has come for an addendum: “If it wasn’t documented, it wasn’t done – but if it wasn’t communicated, it can’t be corrected!” The flow of communication, from investigative sites through monitors to clients (study sponsors) and to regulatory authorities, must be clearly defined and maintained in order to assure the success of a trial.

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  • Developing a Winning FDA Strategy for Clinical Drug Development

    8 October, 2013 Robert L. Kunka, Ph.D., The Kunka Group, Inc.

    The idea of interacting with the FDA is sometimes mysterious and unsettling for a pharmaceutical company. The average person finds it difficult to work with a large organization that they don’t understand. For example, large banks understand this and advertise themselves as the friendly bank that works to help “their neighbors” with buying a house. The FDA’s clients are pharmaceutical companies. Unlike banks, the FDA has significant leverage over the company because it is responsible for reviewing a company’s drug with the hope that FDA will approve it. While many companies are also large, there is no real leverage that the company has over the FDA. Thus, the company is at a distinct unsettling disadvantage. However, both parties have the common desire to market safe and effective drug products. Where the rubber hits the road is that the two parties need to agree on what is needed to demonstrate that the drug is safe and effective.

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  • Innovation and the Quality Process

    8 October, 2013 Ken Peterson, Director of Quality and Consultation Services, MasterControl Inc.

    Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science. At times innovation sends a signal that is in opposition to quality. If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future? Those of us who have a wider view of what innovation should deliver seek entirely new approaches verses conventional problem-solving for cause. It’s not that analytical thinking is unnecessary but on occasion, a new solution unrelated to cause removal is warranted.

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  • MasterControl.Cloud

    5 September, 2013 Victor Gill, MasterControl Inc., Senior Product Manager of Cloud Solutions

    What exactly is Cloud? Or is it, The Cloud? Is it just me, or do no two people describe it the same way? As the product manager over the Cloud initiative at MasterControl, I hear these kinds of questions all of the time. With all of the advertising, mixed messaging, technical jargon, and promises of grandeur, it’s easy to see why so many consumers are confused. At its heart, the term Cloud has been a powerful marketing turn-of-phrase that has consolidated a large mix of technologies.

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  • Review of FDA Guidance "Codevelopment of Two or More New Investigational Drugs for Use in Combination"

    14 August, 2013 Seth A. Mailhot, Special Counsel, Sheppard Mullin Richter & Hampton LLP

    On June 14, 2013, FDA issued the Guidance “Codevelopment of Two or More New Investigational Drugs for Use in Combination.” The guidance discusses FDA’s recommendations for developing an entirely new combination therapy where none of the drugs to be used in combination have been previously developed. FDA notes in the guidance that the recommendations do not apply to combination therapies involving previously developed drugs, or the combination of a new drug with a previously developed drug. While codevelopment has generally been centered in oncology and infectious disease, FDA’s guidance is intended to address codevelopment from a high-level, making it applicable to other diseases.

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  • Elements of Effective Quality Agreements

    14 August, 2013 Steven Sharf, President and Principal Consultant, GMP Concepts

    Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

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  • EU Pharmacovigilance Legislation

    12 June, 2013 by Steve Jolley, SJ Pharma Consulting LLC

    The new legislation represents the biggest change to EU pharmacovigilance requirements since the formation of the European Medicines Agency (EMA) and will have a significant impact for regulators and industry.

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  • Address Root Cause of R&D

    12 June, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Pharmaceutical and biotechnology companies need to address the root cause of their drug development inefficiencies. Most companies focus their efforts on "enhanced clinical trial designs" that use biomarkers and adopt advanced statistical analyses, but they still need to hone their efforts at streamlining their drug development process, according to a recent report by the Tufts Center for the Study of Drug Development.

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  • New Report Highlights Need to Reduce R&D Cost

    19 February, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    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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  • Highlights of the 2012 Revised EU Pharmacovigialnce Regulations

    29 January, 2013 Sidney N. Kahn, Pharmacovigilance & Risk Management, Inc.

    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. The goals of the new requirements are to:

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  • Drug Accountability in Clinical Trials

    3 May, 2012 Dr. Robbie Wong, Pharm.D., Clinical Development Consultant and Affiliate Assistant Professor, Dept. of BioEngineering, University of Washington

    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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  • Implementing a Systems Approach to Parmaceutical Quality Systems

    22 April, 2012 Christine Park, Quality Architech, Christine Park & Associates

    In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn't changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations.

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  • Reducing Human Error on the Manufacturing Floor

    15 June, 2010 MasterControl

    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 where human error investigations should begin.

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