Audit & Assurance
Good Laboratory Practice Audits
Independent GLP compliance assessments for non-clinical safety study facilities and analytical laboratories, aligned to OECD GLP Principles, 21 CFR Part 58 and national GLP monitoring authority requirements.
Executive Overview
Good Laboratory Practice governs the conduct of non-clinical safety studies submitted to regulatory authorities in support of applications for the approval of pharmaceuticals, agrochemicals, medical devices and other regulated products. GLP compliance is not optional for organisations generating safety data for regulatory submission, it is a prerequisite for regulatory acceptance of that data.
OECD GLP Principles establish the organisational and scientific conditions under which non-clinical safety studies must be planned, performed, monitored, recorded, archived and reported. National GLP monitoring authorities conduct compliance assessments of test facilities to verify adherence. Independent audit provides facilities with advance assessment of their GLP status before national monitoring authority inspection.
Sthira Assure GLP audits assess all elements of the GLP quality system: test facility management organisation, QA unit function, standard operating procedures, personnel qualifications, equipment calibration and maintenance, test and reference item management, raw data integrity, archiving arrangements and the accuracy of final reports. We provide findings at the level of specificity that enables targeted remediation before regulatory review.
Regulatory Frameworks
- OECD GLP Principles (1997)
- 21 CFR Part 58 (FDA)
- EU Directive 2004/10/EC
- MHRA GLP Guidance
- OECD Series on GLP
- ISO 17025
Common Compliance Risks
Raw Data Integrity
GLP raw data requirements are among the most stringent in regulated science. Inspectors assess whether raw data is contemporaneous, attributable, legible and preserved in its original form. Transcription of instrument data, retroactive corrections without justification and inadequate audit trails in computerised systems are consistently cited findings.
QA Unit Independence
The GLP Quality Assurance Unit must demonstrate genuine independence from study management. Inspectors assess whether QA activities are conducted at appropriate stages of study conduct, whether findings are reported to study directors and management, and whether QA personnel have the authority and resources to perform their function effectively.
Test and Reference Item Accountability
Accountability for test substances, reference items and vehicle controls is a core GLP requirement. Inadequate characterisation records, storage condition verification failures and discrepancies in receipt, use and disposal records are persistent inspection findings across GLP facilities globally.
Deviations from Study Plans
Protocol deviations must be documented, assessed for impact on study integrity and reported in the final study report. Inspectors find that deviations are frequently undocumented, that assessments of impact on data quality are superficial and that final reports do not accurately reflect all deviations that occurred during study conduct.
Scope of Services
Common Audit Findings
The following represent findings consistently observed during GLP facility and study audits. They reflect systemic gaps that independent assessment routinely identifies before monitoring authority inspection.
Frequently Asked Questions
What is GLP and which organisations must comply?
Good Laboratory Practice is a quality framework governing non-clinical safety studies submitted to regulatory authorities in support of product registrations — pharmaceuticals, agrochemicals, medical devices and other regulated products. Organisations conducting non-clinical toxicology, genotoxicity, pharmacokinetic or environmental fate studies for regulatory submission must comply with OECD GLP Principles and applicable national GLP monitoring authority requirements. Compliance is verified through national monitoring authority inspections of test facilities.
How does a GLP audit differ from a monitoring authority inspection?
A GLP audit conducted by Sthira Assure is an independent, voluntary assessment carried out at the request of the test facility or study sponsor. Its purpose is to identify compliance gaps in advance of national monitoring authority inspection. A monitoring authority inspection is a formal regulatory assessment with legal consequence — non-compliance can result in loss of GLP certification, with direct impact on the regulatory acceptability of study data submitted to product registration authorities worldwide.
Can you conduct in-process audits during live studies?
Yes. GLP in-process audits assess compliance during study conduct rather than retrospectively. They are conducted at critical study phases defined in the study plan and assess raw data recording, equipment operation, test and reference item handling and protocol adherence. In-process audit findings can be addressed while the study is ongoing, whereas retrospective audit findings may not be remediable without impacting study validity.
What is the scope of a test facility management audit?
A test facility management audit examines the organisational elements of GLP compliance: management responsibilities and commitments, QA unit structure and independence, SOP system coverage and currency, personnel qualification and training records, equipment inventory and maintenance schedules, archiving arrangements and the study plan approval and amendment process. Facility audits complement study-specific audits and provide assessment of the systemic GLP compliance environment.
Request a GLP Audit
Contact our team to discuss your GLP compliance requirements and facility assessment scope.