FDA Featured Articles

  1. Human Error Is The Leading Cause Of GMP Deviations – Or Is It? 5/1/2014

    Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick.  Every company wrestles with human error.  We know humans have error rates – we’re not perfect.  But how many is too many?

  2. 5 Questions To Ask Yourself Before The Inspectors Do 3/10/2014

    Since the FDA began releasing its annual Summary of Inspection Observations report in 2006, the number one cited observation in FDA 483s every year has been quality control unit failures. The second most cited FDA observation, failure to thoroughly review unexplained discrepancies/meet expectations, is also the most frequently cited observation by Europe’s Medicines and Healthcare products Regulatory Agency (MHRA). In order to measure your GMP compliance, as well as the effectiveness of your processes and people, ask yourself the following five questions.

  3. Strong Data Is Generated By Strong People 3/7/2014

    By Joanna Gallant, Joanna Gallant Training Associates

    In the event you’ve been living under a rock for the last several months, facility inspection information released by FDA has thrust data integrity into the spotlight.  As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control – assuming we will put the time into executing them. 

  4. FDA And Industry Experts Offer Guidance For DQSA Preparation 3/3/2014

    It’s been over three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it.

  5. ISPE Product Manufacturing Quality Metrics Initiative

    ISPE commenced its Quality Metrics Initiative in June 2013 after the US Food and Drug Administration (FDA) announced its Quality Metrics Program in a February 2013 Federal Register notice. To assist in the evaluation of product manufacturing quality, FDA is exploring the broader use of manufacturing quality metrics.

  6. Three Questions To Consider For DQSA Readiness

    By Dave Colombo and Dawn Wang, KPMG Life Sciences Advisory

    Last November, after much anticipation, the U.S. pharmaceutical industry saw the enactment of the Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). The DSCSA addresses national pharmaceutical track and trace requirements, and industry stakeholders must now prepare themselves for the first round of deadlines for lot-level traceability starting January 1, 2015. In preparation for these guidelines, it is important for companies to follow a framework as they assess their organizations’ readiness to meet DSCSA compliance. A successful program will do so by evaluating the impacts to their business processes and governance, technical solutions, and trading partner relationships.

  7. Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design

    This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka

  8. How To Keep Compliance With Title 21 CFR Part 11 And EU GMP Annex 11

    This white paper analyses the requirements of Part 11 and Annex 11 as they apply to environmental monitoring and validation, and outlines how Vaisala’s Continuous Monitoring System software viewLinc helps firms meet the requirements of both.

  9. The Road To Compliance: Serialization Standardization Through Open-SCS

    As companies around the world implement the necessary changes to comply with serialization policies, it will add an increased level of cost, risk, and especially complexity to today’s operations.