Tag Archive: Annex 1

Reflecting Again on GMP Requirements for Marketing Authorization Holder

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…
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Compliance: Framing Success Utilizing PIC/S and EU GMP

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…
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