Contributing Editors

  1. 4 Focus Areas To Modernize Your Cleaning Validation Strategy 1/30/2023

    The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.

  2. 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.

  3. 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.

  4. Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues 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 itself, explains the reasons behind the revision and delves into the key updates.

  5. Frequent Deficiencies In GMP Inspections, Part 3 1/16/2023

    Don't let cleaning and disinfection methods work against you. Without a system to track cleaning chemicals and equipment, how do you know they haven't expired?

  6. 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.

  7. New Approaches For Drug Substance Freezing And Storage 1/12/2023

    The latest in drug substance-refrigeration technology gives the biopharmaceutical industry options for freezing and storing liquid DS. Here are some insights for optimizing setups based on application, facility, and budget.

  8. 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.

  9. AI/ML In Drug Discovery & Development: Potential And Challenges 1/11/2023

    Selecting the wrong target molecule or focusing on the wrong area of investigation can cause major delays and waste valuable time and resources. Artificial intelligence (AI) and machine learning (ML) can help drug discovery researchers minimize these missteps in a few key ways.

  10. Calculating The Probability Of Passing The USP Dissolution Test 1/9/2023

    Dissolution tests are performed during drug manufacturing to ensure that the drug product meets the standards specified in the United States Pharmacopoeia (USP). This article calculates the probability of passing the USP dissolution test using Microsoft Excel, and it can be modified for any combination of Q, mean, and standard deviations.