Sterile drug

Changes to the size or shape of a container for a non-sterile drug... 

Lack of assurance of sterility in production or testing of sterile drug products. Discoloration. Counterfeit dosage form. 

According to 211.113 Control of microbiological contamination, pharmaceutical manufacturers need written procedures describing the systems designed to prevent objectionable microorganisms in both nonsterile and sterile drug products. All sterilization processes used to manufacture parenteral drugs need to be validated. 

Sterile Drug Produets Produeed by Aseptie Proeessing Current Good Manufacturing Practices... 

For sterile drug substances, an understanding of the drug substance and the sterilization process will help in avoiding potential impurities, for example, compounds formed by the appropriate functional groups of the drug substance reacting with residual ethylene oxide from the sterilization process. 

All product contact surfaces (tubing, filling pumps, and accessories) are cleaned, wrapped, and sterilized prior to use. The sterilized product contact parts are briefly exposed to the level I environment during equipment set-up in which aseptic connections are made with the tubing to transport the sterile drug product to the filling equipment. 

FDA Guidelines on Sterile Drug Products Produced by Aseptic Processing. June, 1987. 

As shown in Table 10 New Zealand s own GMP code consists of five parts. The first part covers the manufacture of drug products and the second part the manufacture of blood products. Part 3 covers compounding and dispensing, including compounding of sterile drug products. Part 4 deals with wholesaling and Part 5 with product recalls. Parts 4 and 5 are combined in one document [31]. 

U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (2004, Sept.), Guidance for industry Sterile drug products produced by aseptic processing—Current good manufacturing practice, DHHS, Rockville, MD. 

Although food preservation has preempted the major share of public attention, sterilized drugs and pharmaceuticals have already achieved a limited market. The reasons for this are apparent when one considers the fact that almost none of the negating factors which are operative in the case of foods come into play here. 

Changes that may affect product sterility assurance including, where appropriate, process changes for sterile drug substances and sterile packaging components. These include ... 

Addition to an aseptic processing line of new equipment made of different materials (e.g., stainless steel versus glass, changes between plastics) that will come in contact with sterilized bulk solution or sterile drug components, or deletion of equipment from an aseptic processing line. 

U.S. Food and Drug Administration, proposed revised Guidelines on Sterile Drug Products Produced by Aseptic Processing. Rockville, MD FDA (Nov. 30, 1998). 

FDA. FDA s proposed current good manufacturing practices (GMP) for regs. for large volume parenterals (LVP). Fed Reg (June 1, 1976). Preliminary Concept Paper of Sterile Drug Products Produced by Aseptic Processing, draft paper, Sept. 27, 2002. 

U.S. Food and Drug Administration (FDA) (2004), Guideline on sterile drug products produced by aseptic processing, FDA, Washington, DC. 

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