PIC/S Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007
Titel:
PIC/S Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007
Kurztitel:
PI 021-2
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 scope of this document is to set at the inspectors’ disposal, a working instrument to increase the performance in GMP inspections performed at a site that manufactures, packages and/ or labels medicinal products for clinical trials used on human subjects.