Rx-360 summary of PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE-009-12)

The Guide covers GMP principles and active substances used as starting materials.

The PIC/S GMP Guide (PE 009-12) has been revised to incorporate revised Annex 15. This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.

This document is effective 1 October 2015. This is the same effective date as EU Annex 15 on Qualification and Validation.