药学英语药学英语 (39).pptVIP

Unit Twelve Good Manufacturing Practices (GMP) Part three These regulations and guidelines may not always be appropriate for the manufacture of clinical trial materials. Although most of the regulations are reasonably applicable in an RD drug product environment, they may become inappropriate where attempts are made to apply them to the early manufacture of clinical APIs within an RD environment. 这些法规和指南可能并不总是适用于临床试验品的生产。 虽然绝大多数的法规适用于制剂研发过程，但将他们应用于研发过程早期的临床试验用原料药的生产就不合适了。 It is only with the issue of the International Conference on Harmonizat