FDA Guidance for Industry: Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes

Titel:
FDA Guidance for Industry: Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
Herkunft/Verlag:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072180.pdf

Inhalt:
Empfehlung an Zulassungseinreicher bzgl. parametrischer Freigabe bei endsterilisierten Produkten

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