TABLE 1: SELECTED LIST OF FDA GMP GUIDANCE
FOR STERILE DRUGS

1. Sterile Drug Products Produced by Aseptic Processing, 1987
2. Validation of the LAL Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, 1987
3. Guideline for Submitting Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, 1994
4. Guidance for Industry; Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, 1999
5. Compliance Policy Guide 7132a.13 Parametric Release of Terminally Heat Sterilized Drug Products, 1987
6. Compliance Policy Guide 7150.16 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices, 1995
7. Compliance Program CP7346.832 “Pre-approval Inspections/Investigations,” 1994
8. Compliance Program CP7346.843 “Post-approval Audit Inspections,” 1992
9. Compliance Program CP7346.002A “Sterile Drug Process Inspections”
10. Foreign Inspection Guide, 1992
11. Laboratory Inspection Guide, 1993
12. Cleaning Validation Inspection Guide, 1993
13. Microbiological Laboratory Inspection Guide, 1993
14. Guide to Inspections of High Purity Water Systems, 1993
15. Lyophilization of Parenterals Inspection Guide, 1993
16. Guide to Inspections of Sterile Drug Substance Manufacturers, 1994