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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
Short Title:PI 021-2
Internet:http://www.picscheme.org/publis/recommandations/PI-2AideMemoire 4520264n 1.#QNANMP -9.25596E+061CP.pdf
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 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.
Document Type:Guide