药学英语药学英语 (36).pptVIP

Unit Twelve Good Manufacturing Practices (GMP) Part five There are fundamental differences between a drug product and API that makes the application of many GMP drug product requirements difficult or inappropriate. An API is normally prepared by chemical processes that involve purification at each stage of manufacture, and early raw materials and processing stages may not have much influence over the quality of the final API. 制剂和原料药有着根本性的区别，这使得许多制剂的GMP要求难以应用或不适合。 原料药通常以化学工艺合成制备，包括生产中每一阶段的纯化。早期的原料和工艺对于最后的原料药的质量不会有很大的影响。 Impurities that are present in the final