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TERMINAL STERILIZATION VALIDATION SHOULD DEMONSTRATE 10

Executive Summary

TERMINAL STERILIZATION VALIDATION SHOULD DEMONSTRATE 10 or better sterility assurance levels, according to a new FDA guideline on NDA/ANDA submission requirements for sterilization process validation. The guideline emphasizes that validation studies for terminal sterilization processes should be submitted in applications demonstrating a 10 sterility assurance level "for all parts of the drug product (including the container and closure, if applicable) which are claimed to be sterile." FDA recognizes that the specific type of study and the methods used to carry out the study or studies "are product and process specific and may vary from manufacturer to manufacturer." However, the guideline states that microbiological challenge studies must demonstrate the 10 efficacy level "under the most difficult to sterilize conditions (e.g., the most difficult to sterilize load with biological indicators at microbiological master sites or in master product or both)." Microbiological master sites or solutions are defined as those "in which it is most difficult to kill the biological indicator under sterilization cycles that stimulate production conditions." The "Guideline for Submitting Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products" was published by FDA in the Dec. 3 Federal Register. Written comments on the guideline should be submitted to the agency by Jan. 3. The document contains separate sections discussing submission requirements on the validation of: moist heat terminal sterilization processes; other terminal sterilization methods including ethylene oxide and radiation; and aseptic fill manufacturing processes. Stability considerations are also addressed. The information contained in the guideline was issued by FDA in preliminary form at a workshop on sterilization process validation sponsored by the agency in Chicago, Ill. in January. Based on the discussions at that conference, FDA issued a revised draft at a follow-up workshop in New Jersey in early June. The agency plans to hold additional workshops on the subject in Europe and California over the next few months. The guideline points out that whether a drug product is sterilized by a terminal sterilization process or by an aseptic filling process, "the efficacy of the sterilization process may be validated without the manufacture of three production batches." However, FDA cautions, "the data should be generated using procedures and conditions that are fully representative and descriptive of the procedures and conditions proposed for manufacture of the product in the application." FDA explains that the scientific evaluation of the validation information submitted in applications "is part of a cooperative effort between the review staff, compliance staff, and field investigators to ensure the overall state of control of the sterile processing" of drug products.

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