PIC/S Guide to Good Manufacturing Practice for Medicinal Products - Annexes

The complete set of annexes to the PIC/S GMP Guide (PE 009), including Annex 1 (sterile products), Annex 11 (computerised systems), Annex 15 (qualification and validation), Annex 19 (reference and retention samples) and Annex 20 (quality risk management). Harmonised with the EudraLex Volume 4 annexes.

Organisaties:

Pharmaceutical Inspection Co-operation Scheme (PIC/S)