Reviewing Laboratories for Compliance with GLP and GMP Requirements

Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (GMP) requirements for pharmaceutical laboratories encompass requirements for the laboratory’s physical facility and environment, quality agreements with lab contractors; the accuracy of instrument calibration and maintenance programs; computer systems; samples and sampling schemes; microbiology practices and procedures; lab SOPs and more. The importance of these schemes for obtaining and reporting credible analytical results leading to a safe and effective product is paramount to the supply chain’s success.

EAS consultants are experts in GLP and GMPs and offer review audits of contractor and supplier laboratories to ensure compliance with required components of each. Our assessment reports allow for a complete understanding of all component areas, a GAP analysis and recommendations for improvements to return to standards.