Guest Columns

  1. Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies 10/29/2024

    In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

  2. Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards 10/28/2024

    A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.

  3. Safety Cabinets' Essential Role In EU GMP Annex 1 10/25/2024

    A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.

  4. Life Sciences Cybersecurity Incident Management: The End-to-End Approach 10/24/2024

    Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.

  5. Exploring Sanofi R&D's Batch Monitoring Initiative 10/23/2024

    The project established predictability during testing and release for the production of medicine to support clinical trials.

  6. What's Next After FDA's DSCSA Extension? 10/18/2024

    Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.

  7. Data Quality Issues At The Heart Of FDA's DSCSA Troubles 10/18/2024

    Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

  8. CDER Wants Your Input On Improving Integrated Reviews 10/17/2024

    CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.

  9. Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL? 10/16/2024

    When choosing your trading partner (CDMO or 3PL), an important element that can be overlooked is serialization and DSCSA compliance. Ensuring these partners can meet requirements is critical.

  10. 3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche 10/11/2024

    Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.