Contributing Editors

  1. 5 Key Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  2. 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

    Microbial contamination control is essential in ensuring consumer safety, especially in controlled environments. Disinfectants play an important role in controlling microbial contamination on surfaces. The term disinfectant is often broadly used to describe chemical agents used to reduce the microbial load of controlled environments.

  3. 7 Steps To Navigate Six Sigma’s “Improve” Phase

    In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

  4. Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

    Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements. Ideally, these documents would have aided industry in developing new products that take advantage of new technologies, given budget and personnel limitations in both the regulatory agencies and industry. And in fact, many of these documents have proposed or emphasized radical changes in strategy and operations, but unfortunately such changes are often met with skepticism and concern by industry.

  5. Launching A New Drug In A Maturing Market — Lessons Learned From Recent COPD Entrants

    Chronic obstructive pulmonary disease (COPD), a global growth market worth well over $15 billion in the U.S. and EU5 in 2016, has long represented a lucrative opportunity for drug manufacturers. However, the proliferation of treatments and increasing number of generics have begun to limit the potential for emerging therapies. A review of the successes and stumbles of the newest class of drugs (LABA/LAMA fixed-dose combinations) illustrates broader lessons manufacturers should consider when launching into a rapidly maturing market.

  6. Brexit, Trump, What Next? 6 Rules To Succeed In An Era Of ‘Brutal Disruption’

    Heard the latest? Elvis is alive and kicking and planning a comeback.  Only kidding … but who knows? After the events of 2016, anything is possible.

  7. PDA Position Paper: A Call For Reform In Global Post-Approval Change Processes

    The seamless delivery of high quality, effective, and safe medicines to patients is each drug company’s ultimate duty. However, providing medication to patients is by no means effortless, as evidenced by the drug product shortage listings on health authority websites. The availability of medicines is challenged by a variety of factors, one of which is global supply chain segmentation due to global regulatory hurdles imposed on product related post-approval changes (PACs).

  8. FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)

    In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

  9. How To Establish Sample Sizes For Process Validation When Destructive Or Expensive Testing Is Required

    This article will discuss how to establish sample sizes for process validation when the testing required is expensive or destructive. Of all the approaches discussed in this series, this one is probably the most difficult to address and statistically justify.

  10. The LAL Assay for Pyrogen Testing Of Parenteral Products: Evolution & Challenges

    The United States Pharmacopeia (USP) harmonized Chapter <85> Bacterial Endotoxins Test describes the procedures for performing Limulus amebocyte lysate (LAL) assays for the detection of endotoxins in pharmaceutical products. This article reviews the development and evolution of the LAL assay, its uses, and misunderstandings that have occurred.