FDA Program 7356.002A Sterile Drug Process Inspections
Title:
FDA Program 7356.002A Sterile Drug Process Inspections
Origin/Publisher:
FDA
Document Type:
COMPLIANCE PROGRAM GUIDANCE MANUAL
Content:
This program covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized.