It can be overwhelming to learn the Good Laboratory Practice Standards for the first time. New employees, possibly familiar with safety procedures and chemical principles, may not be versed in these regulations. Any laboratory that contributes data to a sponsor who submits an application for registration to EPA or FDA should be conducting research under GLPs. These laboratories may find that new hires are not accustomed to working under government regulations and sponsor protocols. The challenge is to present them in such a way as to show their utility while providing a meaningful experience. Part of the role of an independent Quality Assurance auditor is to provide training and guidance in the GLP regulations. Instruction should show employees how to manage raw data in the laboratory, which in turn, can bring the work performed toward registration into perspective. The scope and relevance of GLP training may differ depending on whether the audience are analysts or field technicians, so real world examples should be fine-tuned for the discipline. This multifaceted approach to compliance should begin with explaining the standards themselves and end with learning how to nurture a relationship with QA auditors and inspectors during Agency visits. The generation, management, and archiving of original raw data should be constrained within the Regulations in a facility working on GLP studies. Accomplishing this starts with showing new or seasoned personnel how to navigate and foment favorable habits in compliant document keeping. Within the scope of the Regulations, employees should be taught raw data documentation, keeping equipment maintenance logs, responding to QA audits, and contributing to revisions of facility documents. Showing new hires, that in conjunction with standard operating procedures and protocols, knowing and adhering to the GLPs will improve the quality of data that is submitted.

Effective GLP instruction for new laboratory personnel

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.