Laboratory Control System Checklist: Methods Validation and Technology Transfer

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. Methods Validation is the process of demonstrating that analytical procedures are suitable for their intended use. The methods validation process for analytical procedures begins with the planned and systematic collection validation data to support analytical procedures. In addition, the methods validation process is considered to be complete once the methods have been successfully transferred from the originating to the receiving or end user laboratory. Methods Validation and Technology Transfer includes at least three individual topics. A laboratory, which is in compliance with CGMPs, should at least address each of these topics. These topics include: (1) Validation of Analytical Methods-General, (2) Cleaning Methods Validation, and (3) Procedures for Methods Transfer. This checklist is a modifiable 8 page Microsoft® Word document. This product is available for download.