GLP Audits

Non-clinical safety data underpins first-in-human and regulatory decisions, so the test facility and the study that produced the data must be demonstrably compliant. A reliability problem discovered late — at submission, or worse, at inspection — can invalidate pivotal studies and reset a program. PharmExpert performs Good Laboratory Practice audits of test facilities, study-based activities and the GLP quality system against the OECD Principles of GLP and US FDA 21 CFR Part 58.

At facility level, we assess organization and management, the independence and effectiveness of the Quality Assurance Unit, facilities and equipment, archives, and the SOP and documentation framework. At study level, we follow a specific study against its approved plan — examining conduct, raw data, test- and reference-item characterization and handling, and the roles of the Study Director and personnel.

Data integrity runs through everything we examine. Whether records are paper or electronic, we assess whether they are attributable, contemporaneous, original and accurate, and whether computerized systems are controlled against tampering and loss. Increasingly, the reliability of a GLP study hinges on the configuration and governance of its instruments and data systems as much as on the science.

The result is an objective, referenced report that tells you not just where the gaps are, but what they mean for the reliability of the data and how to close them. Whether you are a sponsor qualifying a non-clinical CRO or a test facility preparing for a monitoring-authority inspection, the audit protects the decisions that rest on the study.