Keller C D, Taulbee S M
Research Triangle Institute, Research Triangle Park, North Carolina 27709, USA.
Qual Assur. 1995 Mar;4(1):83-6.
The Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals as found in 21 CFR 211 is specifically geared to the regulation of drug-manufacturing processes in industry. However, under some circumstances, it becomes necessary to apply the regulation to manufacturing operations in a research laboratory setting. Application of the regulations in such a setting requires management commitment, cooperation between QA/QC and technical staff, patience, creativity, and an understanding of the spirit behind the letter of the law. Breaking down the regulations into their fundamental parts gives insight into the intent of the regulations and aids in their application. This article will outline our experience in applying the cGMP in a research laboratory setting.
《联邦法规汇编》第21篇第211节中的成品药现行药品生产质量管理规范（cGMP）专门针对制药行业的药品生产工艺进行监管。然而，在某些情况下，有必要将该法规应用于研究实验室环境中的生产操作。在这种环境下应用法规需要管理层的支持、质量保证/质量控制（QA/QC）部门与技术人员之间的合作、耐心、创造力以及对法律条文背后精神的理解。将法规分解为基本部分有助于深入了解法规意图并便于应用。本文将概述我们在研究实验室环境中应用cGMP的经验。
