Contributing Editors

  1. These Were FDA's Top Citation Issues For Data Quality In 2024 1/31/2025

    Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.

  2. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

    This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

  3. Are Plant-Based APIs The Future Of Pharma And Nutraceuticals? 1/29/2025

    As consumer preferences for natural and organic products rise, pharma and nutraceutical companies are increasingly shifting to plant-based APIs. This article shares new market research, including a spotlight on cannabis-based APIs.

  4. Top 10 Data Auditor Statistical Software Requests 1/27/2025

    Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.

  5. Computer Systems Validation Pitfalls, Part 4: Inattention To Details 1/24/2025

    The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.

  6. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

    The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

  7. Addressing Blind Spots In Assuring Therapeutic Equivalence 1/14/2025

    The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.

  8. A Justification For Using In-Process Controls In Place Of Cleaning Validation 1/9/2025

    This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.

  9. 7 Focus Areas To Establish A Win-Win Relationship With Your CDMO 1/7/2025

    Working with a CDMO doesn’t always go as planned. This article outlines the factors that will impact project success and set up a “win-win” relationship.

  10. Deploy AI To Become A cGMP 'Special Agent' With A License To Care 1/7/2025

    Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."