GUEST COLUMNISTS

  • Top 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter In 2019

    In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.

  • Using Production And Postmarket Data To Validate FMEA Assumptions

    One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.

  • 3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers

    Amid this opportunity for generic drug makers to capitalize on patent expiration, they’re facing struggles around pricing power. COVID-19 also exposed the fragility of supply chains that were built with economic efficiency rather than resiliency in mind.

  • An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

    The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019. 

  • Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues

    The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.

  • 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement

    This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.

  • Facility Design & Construction Tips For Up-Start Biotech Companies

    Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.

  • Seeing Double: Using Digital Twins To Improve Pharma Processes

    The pairing of the virtual and physical worlds not only enables systems to be adapted or repaired from afar, but the approach also further enables the analysis of data and monitoring of systems to avoid problems before they even occur.

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This e-book is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. It is intended to aid the practitioner avoid regulatory compliance issues. To that end, each technique provides the context for its application, formula(s), variables, and a fully worked example to help understand and apply the technique. Additionally, each technique demonstrates the linkage to risk to help demonstrate “a high degree of assurance.”

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