FDA Sterilization Process Validation, January 1993
Title:
FDA Sterilization Process Validation, January 1993
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA
Document Type:
FDA guidance for industry
Content:
These FDA guidelines for the validation of sterilization methods were compiled by the Center for Veterinary Medicine and by the Center for Drug Evaluation and Research. They contain recommendations as to which information about the validation of the sterilization methods used must be communicated to FDA when applying for marketing authorization for human and veterinary medicinal products.