Laboratory Control System Checklist: Laboratory Managerial and Administrative Systems

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 Managerial and Administrative Systems are those elements which provide the infrastructure for efficient and compliant operations of an analytical laboratory. Laboratory Managerial and Administrative Systems elements include at least eight individual topics. A laboratory which is in compliance with CGMPs should at least address each of these topics (as applicable). These topics include: (1) Organizational Structure and Roles and Responsibilities, (2) Training, (3) Tracking and Trending-Statistical Quality Control, (4) Complaints, (5) Laboratory Purchasing and Requisition, (6) Laboratory Administration, (7) Laboratory Chemicals, Solutions, Reagents and Supplies, and, (8) Laboratory Reference Standards and Solutions. This checklist is a modifiable 21 page Microsoft® Word document. This product is available for download.