| Sterilization means that the survival rate of the microorganisms in products should be reduced to a certain level, and the probability of viable microorganism in terminally sterilized product should be less than 10-6 in terms of sterility assurance level (SAL). For terminally sterilized product, sterility test is to check the possible problems during sterilizing process as the final control for sterility. The discrepancy of the analysis results always exists no matter how perfect the statistic sampling technique is, and so it cannot ensure the 'sterility' of a sterile product just judged by the results of sterility analysis. 'Parametric release' is a release system that drug manufacturing enterprises use to evaluate the sterility of a product based on effective control , monitoring and the data of sterilization process validation, substituting the system based on sterility test results of finished products. This project is to study sterility analysis limitation ,the theoretical foundation of the sterility assurance and performing parametric release for the finally moist heat sterilized product, the laws and regulations and also key control factors in parametric release, to take the strict measure of quality control, scientific selection of process parameter and effective test , and to make sure that the risk of defective sterile product flowing into the market is not increased through strict quality control measures, scientific choice of process parameters, and effective validation after canceling the sterilizing test.1. The current international and domestic status of parametric releaseIn 1987, the Food and Drug Administration (FDA) of United States promulgated "Parametric Release Policy Guide", making the application and practice of parametric release legalized and thus the parametric release was carried into the history of GMP development. Then Australia, Singapore, Canada, Brazil, Chile, Colombia, Germany,...
|
PDF Full Text Request