浅谈如何保证药品生产企业实验数据的准确和可靠性

Discussion on How to Ensure the Accuracy and Reliability of Experimental Data in Drug Producing Enterprises

药品是用于治病救人,如何能保证药品能够达到预期药效而不影响使用人员的身体健康,生产企业的生产工艺稳定和质量保证是保障,但是如何能够体现生产企业工艺稳定那就得从生产企业实验数据来考察,因此实验数据必须是准确和可靠的,为了保证实验数据的准确和可靠,笔者主要从人、机、料、法、环五个方面来考虑,并与同道探讨。

Medicines are used to cure diseases and save lives. About how to ensure that medicines can achieve the expected efficacy without affecting the health of users, the process stability and quality assurance of production enterprises are the guarantee. But regarding to how to reflect the process stability of produing enterprises, it needs to be investigated from the experimental data of production enterprises. Therefore, the experimental data must be accurate and reliable. In order to ensure the accuracy and reliability of experimental data, the author mainly considers from five aspects, namely, man, machine, material, method and environment, and discusses with fellow researchers.