[Validation and environmental control of preparation operations. Fifth communication of the Comite des Laboratoires et Services Officiels de Controle des Medicaments et de la Section des Pharmaciens de l'Industrie'-F.I.P, May 1990].
The many different check-points concerning the complementary activities of validation and monitoring of aseptically processed pharmaceutical preparations are described. The features are based on the official and current GMP guidelines. These are outlined in practical terms according to the personal experience of the authors and manufacturing specialists who were consulted.
D004345:Drug Industry / Q000592:standards*; D005602:France; D011786:Quality Control
Validation et contrôle de l'environnement des opérations de fabrication aseptique. 5e Rapport commun du Comité des Laboratoires et Services Officiels de Contrôle des Médicaments et de la Section des Pharmaciens de l'Industrie--F.I.P. mai 1990.