Guest Columns

  1. Considerations For Microbial Enumeration Methods When Working With CDMOs 1/23/2023

    In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.

  2. EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products 1/18/2023

    The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

  3. What's Behind The ASTM E3263 Standard Revision? 1/17/2023

    ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.

  4. Considerations For Sterility Test Methods When Working With CDMOs 1/13/2023

    Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.

  5. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

    The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

  6. FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections 1/9/2023

    The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.

  7. Will ESG Be 2023’s Hottest Business Topic In Bio/Pharma? 1/6/2023

    Sustainability used to be just about saving the planet. Today it has morphed into an umbrella term for environmental, social, and governance (ESG) issues. Mentions of ESG and related topics in pharma companies’ filings more than tripled between 2016 and 2021. What are the commitments that companies are making, and which Big Pharma companies are making those commitments?

  8. Why Location Matters 1/5/2023

    While many factors can dictate the choice of a CDMO partner, the CDMO's location can have a significant influence on the communications channels, facilities, and skillsets that a potential partner has to offer.

  9. CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance 12/21/2022

    While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.

  10. Cleanroom Gowning Programs Compliant With EU GMP Annex 1 12/15/2022

    Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.