GxP Lifeline

 

Showing items tagged as Pharma

  • Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner

    February 14, 2014 Lisa Weeks, Marketing Communications, MasterControl Inc.

    Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

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  • Where Are You in Your Quality Management Maturity?

    January 31, 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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  • 6 Ways to Leverage Risk-Based Monitoring & Clinical CAPA

    November 14, 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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  • Elements of Effective Quality Agreements

    August 14, 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

    June 12, 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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  • New Report Highlights Need to Reduce R&D Cost

    February 19, 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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  • Drug Accountability in Clinical Trials

    May 3, 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

    April 22, 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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