Levchuk J W
Food and Drug Administration, Rockville, Maryland.
J Parenter Sci Technol. 1991 May-Jun;45(3):152-5.
Quality characteristics must be assured through adherence to good manufacturing practices in the production, control, and testing of drug products intended for investigational as well as commercial use. A draft guideline on the preparation of investigational new drug products, soon to be available in final form, addresses questions that have been raised regarding acceptable practices and procedures to facilitate compliance with the CGMP regulations as applied to clinical supplies. Inspections of sterile clinical supplies production can be expected to include the areas most likely to influence product safety, quality, and uniformity in the same manner as would be expected regarding the manufacture of commercial batches. Some areas of particular significance in the manufacture of parenteral clinical supplies include validation of terminal sterilization, aseptic processing, and oxygen exclusion. The validation of the aseptic handling during lyophilization requires special attention. Other CGMP concerns include the provision of a quality control unit, avoiding packaging mixups, and being prepared for an amendment to the CGMP regulations regarding terminal sterilization.
必须通过在用于研究和商业用途的药品生产、控制及测试过程中严格遵守良好生产规范来确保质量特性。一份关于研究用新药产品制备的指南草案即将定稿，该草案解决了一些关于可接受做法和程序的问题，以促进遵守适用于临床供应品的CGMP法规。预计对无菌临床供应品生产的检查将涵盖与商业批次生产相同的、最有可能影响产品安全性、质量和均匀性的领域。在肠胃外临床供应品生产中，一些特别重要的领域包括终端灭菌验证、无菌工艺和氧气排除。冻干过程中无菌操作的验证需要特别关注。其他CGMP问题包括设立质量控制部门、避免包装混淆以及为关于终端灭菌的CGMP法规修订做好准备。
