Compliance: Framing Success Utilizing PIC/S And EU GMP

By LeAnna Pearson

Established in 1995 as an extension of the Pharmaceutical Inspection Convention (PIC), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) operates as a non-binding cooperative arrangement involving 56 regulatory authorities. The organization's overarching mission is to spearhead the international development, implementation, and maintenance of harmonized Good Manufacturing Practice (GMP) standards and quality systems for inspectorates in the realm of medicinal products. Membership in PIC/S is exclusive to regulatory authorities, barring individuals and companies from joining or influencing the authoring of the guidance when written.

In conjunction with the enforcement of Annex 1, PIC/S published a new guidance document entitled "Guide to Good Manufacturing Practice for Medicinal Products Annexes," on August 25, 2023. This seems to align serendipitously.

This article delves into the differences between the PIC/S GMP Guide and the EU GMP Guides, offering a recap of the Annex 1 revision. Additionally, it provides insights into the collaborative efforts between the FDA, MHRA, and PIC/S.