PIC/S Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-3)
Titel:
PIC/S Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-3)
Kurztitel:
PI 024-3
Internet:
Herkunft/Verlag:
Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Inhalt:
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.