PIC/S PS/INF: Guide to GMP for Medicinal Products, Qualification and Validation – Annex 15, 4/15

PIC/S PS/INF: Guide to GMP for Medicinal Products, Qualification and Validation – Annex 15, 4/15

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Annex 15 now refers readers to Annex 11, Computerised Sytems, for the specific details regarding validation of computer systems.

Description

PIC/S PS/INF: Guide to GMP for Medicinal Products, Qualification and Validation – Annex 15, 4/15

In April, 2015, PIC/S adopted Eudralex Annex 15, Qualification and Validation. This revision of Annex 15 takes into account changes in manufacturing technology.

Annex 15 now refers readers to Annex 11, Computerised Sytems, for the specific details regarding validation of computer systems.

The deadline for compliance with this version of Annex 15 was 01-OCT-2015.

Issuing Body PIC/S Guidance
Date Published 2015

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