The FDA cited violations to good manufacturing practice. FDA引证兰伯西违反了良好生产规范。
Secondly, the enterprises engaged in drug manufacture and trade should be regulated by the Good Manufacturing Practice(GMP) ( GMP ) and Good Selling Practice ( GSP ). 其次,参与药品生产和销售的企业应该受到GMP和GSP的监管。
He introduced a Chinese version of Good Manufacturing Practice(GMP) guidelines, which ensure that production is up to standard and that a mechanism is in place to deal with drug problems. 他组织起草了GMP指南的中国版,使得药品生产符合规范,并引入一套机制来处理药品问题。
The agency rapidly set up mechanisms to ensure adherence to drug standards, including enforcing good manufacturing practice and centralising drug approvals. 药监局也迅速地建立了一整套机制来确保药品质量,这包括强制推行GMP认证和废除地方药物标准,统一药物审批权。
American Drug Manufacturing Science and Its Implication for Good Manufacturing Practice(GMP) of Drugs in China; Discussion On the Management of Deviations in the Process of the Pharmaceutical Production by the Pharmaceutical Manufacturers 美国药品生产科学及对我国药品生产质量管理的启示浅谈药品生产企业在药品生产过程中的偏差管理