Featured Pharma Online Editorial

  1. ISO 22519: An Unnecessary, Faulty, And Confusing Standard
    10/11/2019

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  2. FY2018 FDA Drug Inspection Observations And Trends
    10/7/2019

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  3. Facilitating Data Integrity Through Risk-Based Confirmation Of Performance
    10/2/2019

    We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?

  4. Analysis: FDA’s Draft Guidance On Premarket Combination Products Review
    9/20/2019

    Guideline on the Quality Requirements for Drug-Device Combinations (EU) and Principles of Premarket Pathways for Combination Products (U.S.) are the latest attempts to regulate combination products. Here, we examine the two guidances in detail, beginning with the U.S. regulatory guidance.

  5. Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data
    9/18/2019

    This article explores some of the typical issues that may be encountered during recovery studies, and explains how the use of statistical tools for assessing recovery data can provide greater insight to guide decisions concerning recovery studies. 

  6. FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
    9/16/2019

    This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

  7. Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again
    9/12/2019

    Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.

  8. FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    9/4/2019

    In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

  9. Is Your Personnel Hygiene Plan Up To Date?
    8/27/2019

    Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

  10. How To Prepare For An FDA Inspection
    7/29/2019

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.