GLP — Good Laboratory Practice
Ensuring Preclinical Data Integrity & Study Replicability
Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. Arirex provides deep-dive technical audits of preclinical facilities to ensure the integrity of laboratory data submitted to health authorities worldwide (FDA, EMA, OECD).
Core Technical Audit Focus
QA Unit Independence & Test Systems
- Quality Assurance Oversight: Verification of the Quality Assurance (QA) unit’s independence from study management and its effectiveness in protocol review, master schedule maintenance, and phase-specific inspections.
- Test Item Characterization: Auditing the handling of test and reference items, including purity, stability, and chain of custody.
- Animal Care & Facilities: Assessment of viva-rium environmental controls, hygiene protocols, and diagnostic laboratory oversight.
Study Conduct & Data Integrity
- Protocol Adherence: Step-by-step verification of study execution against the approved study protocol and Standard Operating Procedures (SOPs).
- Electronic Data & LIMS: Technical audit of Laboratory Information Management Systems (LIMS), focusing on 21 CFR Part 11 compliance, raw data metadata, and audit trail reviews.
- Archiving & Specimens: Assessment of long-term storage conditions for raw data, specimens, and final reports to ensure replicability.
Regulatory Standards & References
- OECD: Principles of Good Laboratory Practice (GLP) and consensus documents.
- FDA: 21 CFR Part 58 (GLP for Nonclinical Laboratory Studies).
- EPA: 40 CFR Part 160 (FIFRA) and Part 792 (TSCA) requirements.
- Health Canada: Guidance for Preclinical safety study submissions.
The ARIREX Deliverable
Our GLP audits bridge the gap between scientific execution and regulatory expectation. We provide the independent verification required to ensure your preclinical data is robust, ethical, and ready for regulatory scrutiny during IND/NDA/BLA submissions.