Laboratory Control System Checklist: Laboratory Documentation Practices and Standard Operating Procedures

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. Laboratory Documentation Practices and Standard Operating Procedures form a critical component of the overall Laboratory Control System. Much of the essence of CGMPs involves the generation, review, approval, revision and control of procedures and data. In compliance parlance, “If it isn’t written down, it didn’t happen.” Laboratory Documentation Practices and Standard Operating Procedures includes at least nine individual topics. A laboratory, which is in compliance with CGMPs, should address each of these topics (as applicable). These topics include: (1) SOPs-General, (2) SOPs-Specific Topics, (3) Laboratory Test Procedures, (4) Laboratory Data and Results, (5) Security of Data, (6) Distribution of Results, (7) Chromatography, (8) In-Process Testing, and (9) Assignment of Re-Test/Expiry Dates. This checklist is a modifiable 22 page Microsoft® Word document. This product is available for download.