1. Current good manufacturing practices for finished pharmaceuticals;Food and Drug Administration;Fed. Reg.,1978
2. Guide to Inspection of Bulk Pharmaceutical Chemicals, Food and Drug Administration, Rockville, MD (September, 1991).
3. Guideline on Sterile Drug Products Produced by Aseptic Processing;Food and Drug Administration,1987
4. Aseptic processing of non-preserved parenterals;Avallone;J. Parenteral Sci. Tech.,1989
5. CGMP inspection of new drug products;Avallone;Pharm. Tech.,1989