Dokumentation om steril respektive icke-steril tillverkning

EC Guide to Good Manufacturing Practice, Annex 1, Manufacture of Sterile Medicinal Products

Food & Drug Administration, Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice

World Health Organization WHO Technical Report Series, Annex 6, Good manufacturing practices for sterile pharmaceutical products, No. 902, 2002

IFF guidelines, IFF Vejledning om hygiejnisk monitorering i ikke-steril lægemiddelproduktion

 

 

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