April 26, 2024 || Geraldine Carr-Mulry
Annex 21 went into effect on August 21, 2022. It’s time to check that processes and procedures have not fallen short of the actual requirements specified in this guideline and to consider whether this guideline has helped manufacturers, healthcare providers, and patients. So, what is Annex 21? Annex 21 details the GMP…
March 18, 2024 || Brian Stephens
This is the second in a series of three articles that present lessons that our validation team learned while completing a pair of validation projects that used the FDA’s draft of the Computer Software Assurance for Production and Quality System Software Guidance (CSA). The number of resources, the amount of…
February 12, 2024 || Brian Stephens
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer Software Assurance guidance in September 2022. Since that time, I have used this guidance to reduce the effort and cost required to complete two large…
November 27, 2023 || Geraldine Carr-Mulry
In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This paper, updated in January 2022, serves as an important guideline for MAH to understand their GMP responsibilities, especially in cases where they may not be…
November 21, 2023 || LeAnna Pearson
Introduction PIC/S was founded in 1995 as an extension of PIC (Pharmaceutical Inspection Convention). They are a non-binding cooperative arrangement between 56 different Regulatory Authorities. Just seeing the number 56 does not have the same impact as seeing the map below and understanding the true global reach of PIC/S. Their…
