Laboratory Control System Checklist:: Laboratory Investigations

This Laboratory Control System Checklist is meant to be used to audit your laboratory for compliance with the Quality Systems Based approach to Lab CGMPs. CGMPs exist to not only prevent problems from occurring, but to mitigate and address deficiencies when they do occur. The Laboratory Investigations sub element is designed to systematically identify the root cause of failures determine how to correct the problems, and to prevent them from re-occurring in the future. Laboratory Investigations includes at least three individual topics. A laboratory, which is in compliance with CGMPs, should address each of these topics (as applicable). These topics should include: (1) Laboratory Investigations-General, (2) Laboratory Investigations-Execution, and (3) Laboratory Investigations-Documentation. This checklist is a modifiable 10 page Microsoft® Word document. This product is available for download.