The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Program 7356.002A Sterile Drug Process Inspections
Internet:
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.
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