Geigert J, Klinke R, Carter K, Vahratian A
Immunex Manufacturing Corporation, Bothell, Washington.
PDA J Pharm Sci Technol. 1994 Sep-Oct;48(5):236-40.
If ever clear instruction and close teamwork is needed, it is in the validation of manufacturing processes. All members of the Validation Team need to understand how the Quality Control testing fits into the overall validation work plan. This affords the team members the opportunity to understand how data will be used and avoids a situation where the test results either invalidate or inadequately support the validation plan. A case example is presented for an approach used to validate Clean-in-Place (CIP) procedures for 1600 L bioreactors which are operated on a campaign basis for multi-biopharmaceutical synthesis.
如果说有什么工作需要清晰的指令和紧密的团队合作，那就是生产工艺的验证。验证团队的所有成员都需要了解质量控制测试如何融入整体验证工作计划。这使团队成员有机会了解数据将如何使用，并避免出现测试结果使验证计划无效或无法充分支持验证计划的情况。本文给出了一个案例，介绍了一种用于验证1600升生物反应器在位清洗（CIP）程序的方法，这些生物反应器在多生物制药合成的批次生产基础上运行。
