Considerations When Implementing Automated Methods into GxP Laboratories

In the increasingly scrutinized pharmaceutical industry, regulatory agencies are demanding validation of any and all analytical instrumentation, including documentation associated with its implementation, qualification, and ability to report accurate and reliable results. Herein, we discuss the qualification and validation of an automated liquid handling system and an automated dissolution method. We describe the comparison of automated experiments versus manual experiments while addressing the pertinent validation and qualification considerations for each. Discussion of documentation and validation required for various regulated laboratories (good clinical practices (GCP), good laboratory practices (GLP), and good manufacturing practices (GMP)) is also reviewed.