FDA Guidance for Industry: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
Titel:
FDA Guidance for Industry: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
Internet:
Herkunft/Verlag:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072171.pdf
Inhalt:
Nachweis der Effizienz des Sterilisationsverfahrens in der Zulassung bei Human- und veterinärarzneimitteln