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PIC/S Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-2) Sept 2007

Short Title:
PI 024-2
Origin/Publisher:

Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org

Content:
The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy products. It includes also products for use in clinical trials. The aide memoires should be considered as a non-exhaustive list of areas to be looked at during an inspection.

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