Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry

 Analytical validation is required as the basis for any evaluation activities during manufacturing process validation, cleaning validation and validation of the testing method itself in the pharmaceutical industry according to good manufacturing practice (GMP) rules and guidelines. Validation of analytical methods and procedures in a quality control (QC) laboratory is implemented mainly at the time of transfer or introduction of the methods developed by the analytical development laboratory within group companies or elsewhere. However, it is sometimes necessary to develop a new or improved method of analysis for the QC laboratory's own use. In the first part of this report, a general description of analytical validation of the high performance liquid chromatography (HPLC) method including preparation of documents is presented based on the experience in our QC laboratory. A typical example of method validation of robotic analysis system is then cited. Finally the merits and demerits of these analytical validations for QC laboratories are summarized. The authors emphasize the importance of analytical validation and the responsibility of QC laboratory management for the effective design and implementation of validation activities.