Bansal Surendra K, Layloff Thomas, Bush Ernest D, Hamilton Marta, Hankinson Edward A, Landy John S, Lowes Stephen, Nasr Moheb M, St Jean Paul A, Shah Vinod P
Hoffmann-La Roche Inc, Nutley, NJ 07110, USA.
AAPS PharmSciTech. 2004 Apr 2;5(1):E22. doi: 10.1208/pt050122.
The purpose of the use of analytical instruments is to generate reliable data. Instrument qualification helps fulfill this purpose. No authoritative guide exists that considers the risk of instrument failure and combines that risk with users' scientific knowledge and ability to use the instrument to deliver reliable and consistent data. In the absence of such a guide, the qualification of analytical instruments has become a subjective and often fruitless document-generating exercise. Taking its cue from the new FDA initiative, “Pharmaceutical GMP's for the 21st Century,” an efficient, science- and risk-based process for AIQ was discussed at a workshop on analytical instrument qualification. This report represents the distillate of deliberations on the complicated issues associated with the various stages of analytical instrument qualification. It emphasizes AIQ's place in the overall process of obtaining quality reliable data from analytical instruments and offers an efficient process for its performance, one that focuses on scientific value rather than on producing documents. Implementing such a process should remove ambiguous interpretations by various groups.
使用分析仪器的目的是生成可靠的数据。仪器确认有助于实现这一目的。目前没有权威指南考虑仪器故障风险，并将该风险与用户的科学知识及使用仪器提供可靠且一致数据的能力相结合。由于缺乏这样的指南，分析仪器的确认已变成一种主观且往往徒劳无功的文件生成活动。基于美国食品药品监督管理局（FDA）的新举措“21世纪药品生产质量管理规范（GMP）”所提供的思路，在一次分析仪器确认研讨会上讨论了一种高效、基于科学和风险的分析仪器确认（AIQ）流程。本报告是对与分析仪器确认各阶段相关复杂问题进行审议的精华总结。它强调了AIQ在从分析仪器获取高质量可靠数据的整体过程中的地位，并提供了一种高效的AIQ实施流程，该流程侧重于科学价值而非生成文件。实施这样的流程应能消除各团体的模糊解读。
