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  1. Mikrobiologisches Monitoring zur Uberwachung der Hygieneanforderungen des EG-Leitfadens einer Guten Herstellpraxis für Arzneimittel. II: Durchführung des Monitoring.

    Article - En allemand

    Traduction en anglais : Microbiological monitoring for inspection of hygiene requirements of the EEC-guide to good manufacturing practice for medicinal products. II Execution of monitoring.

    Microbiological Monitoring for Inspection of Hygiene Requirements of the EEC-Guide to Good Manufacturing Practice for Medicinal Products/Part 2: Execution of monitoring After the requirements have been presented in the first part, this part describes the practical execution.

    Not only questions of method are handled here, but the frequency and timing of the inspections are also discussed.

    Apart from this, completed investigations are presented- method validation, identification of organisms found and trend analysis.

    Mots-clés Pascal : Industrie pharmaceutique, Contrôle qualité, Hygiène, Fabrication, Médicament, Qualité air, Qualité eau, Personnel, Désinfection, Surface, Réglementation, CEE, Contrôle microbiologique, Bonne pratique fabrication

    Mots-clés Pascal anglais : Pharmaceutical industry, Quality control, Hygiene, Manufacturing, Drug, Air quality, Water quality, Personnel, Disinfection, Surface, Regulation, EEC, Microbiological testing

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 93-0524852

    Code Inist : 002B30A08. Création : 199406.