Featured Pharma Online Editorial

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 Analysis: FDA’s Draft Guidance On Premarket Combination Products Review 9/20/2019

    The new EU draft guidance Guideline on the quality requirements for drug-device combinations and U.S. draft guidance Principles of Premarket Pathways for Combination Products are the latest attempts by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail, starting with the U.S. guidance.

  2. 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. 

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 3 Surefire Approaches To SOP Harmonization 7/25/2019

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  9. 4 Trends In Recent FDA Warning Letters To OTC Drugmakers — And How To Avoid Them 7/19/2019

    A recent flurry of warning letters issued to manufacturers of over-the-counter (OTC) drug and health products has revealed similar deficiencies related to current good manufacturing practice (GMP) and quality management expectations.

  10. 4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes 7/17/2019

    Bias can take many forms and is often not easily recognized by an investigator. Sherlock Holmes was keenly aware of bias' potential impacts. Applying more of Holmes’ famous observations and investigative principles can uncover hidden bias and greatly increase an investigator’s chance of finding that elusive definitive root cause.