Preclinical (GLP) — Good Laboratory Practice
Ensuring Laboratory Data Integrity & Study Replicability
Good Laboratory Practice (GLP) is essential for non-clinical health and environmental safety studies. Arirex provides independent auditing of preclinical laboratories to ensure that studies are planned, performed, monitored, recorded, archived, and reported with the highest level of integrity.
Our GLP Audit Scope
Laboratory Operations & Study Conduct
- Audits of toxicology, pharmacology, and analytical laboratories supporting IND/IMPD/PMA submissions.
- Verification of study protocols, raw data capture, and final report accuracy.
- Standards: OECD Principles of GLP, FDA 21 CFR Part 58.
Test System & Equipment Qualification
- Review of test system characterization (animal models, cell lines, chemical agents).
- Assessment of equipment calibration, maintenance, and computer system validation (CSV) in the lab.
Data Quality & Archiving
- Evaluation of Quality Assurance (QA) unit effectiveness and independence.
- Review of specimen and raw data storage, long-term archiving protocols, and retrieval discipline.
Mock Regulatory Inspections
Simulated FDA / EMA / MHRA Inspection Environment
Arirex recreates the structure and intensity of real regulatory inspections based on FDA QSIT, EMA GMP inspection procedures, and MHRA GMP guidance. Our simulations mimic:
- Document request behavior
- Interview patterns
- Evidence follow up
- Daily inspection rhythm
- Facility walkthrough expectations
SME Coaching & War Room Training
We prepare Subject Matter Experts to respond to regulators confidently and effectively. Coaching focuses on:
- Clear, concise, factual responses
- Evidence retrieval discipline
- Staying within scope of expertise
- Handling silence and follow up questions
- War room organization and communication flow
Inspection Style Observation Reporting
Mock inspections conclude with a structured, regulator style report categorizing findings with direct references to applicable sections of CFRs, EMA Annexes, MHRA guidance, or other global standards.
Internal Audit & Mock Inspection Deliverables
Arirex provides inspection grade outputs that enable focused, rapid, and sustained improvement.
Internal Audit Deliverables
- Comprehensive internal audit report
- Detailed observations categorized by severity (Critical, Major, Minor, OFI)
- Direct citations to ISO, CFR, Annex, and guideline requirements
- QMS subsystem effectiveness ratings
- Data integrity (ALCOA+) gap assessment
- Supplier qualification status with risk ratings
- Audit trail and documentation sampling analysis
- Cross audit trend summary
- Executive summary for leadership visibility
Mock Inspection Deliverables
- FDA/EMA/MHRA style inspection observation report (483 like format)
- Daily inspection notes and evidence request logs
- CFR / Annex mapping for every finding
- Inspection readiness scorecard
- SME communication performance feedback
- War room readiness assessment
- Comprehensive debrief session
- Prioritized remediation and CAPA pathway
CAPA & Follow Up Deliverables
- Root cause verification summary
- Effectiveness check plan and timelines
- CAPA closure readiness evaluation
- Long term QMS improvement roadmap
These deliverables ensure your organization understands regulatory expectations, addresses gaps efficiently, and maintains sustained inspection readiness.
CAPA Performance & Remediation Support
An audit is only impactful if the findings lead to meaningful, lasting corrective action. Arirex strengthens your CAPA system through:
- Root cause analysis validation
- Corrective action suitability assessments
- Effectiveness checks and prevention strategies
- CAPA closure verification
- Systemic improvement recommendations
Inline reference: ICH Q10 (Pharmaceutical Quality System).
Our guidance ensures that every CAPA addresses real root causes, eliminates recurrence, and elevates long term QMS performance.
Regulatory References
- ISO 19011:2018
- FDA QSIT Guide
- EMA GMP Inspection Framework
- MHRA GMP Guidance
- ICH Q10 (Pharmaceutical Quality System)
Ensure your team is inspection ready and audit strong.
Book your Internal Audit or Mock Inspection todayGlobal Supply Chain Quality Brief
Submit the briefing form below and an Arirex senior lead auditor will contact you within 24 hours to discuss your specific needs.
1. Contact Information
- Full Name: ___________________________
- Company Name: ________________________
- Email Address: ________________________
- Phone Number: ________________________
2. Audit Scope & Standards
Select the primary focus of your request:
- [ ] Pharmaceutical/Biologics (GMP, GDP, GCP, GVP, GLP)
- [ ] Medical Device/IVD (ISO 13485, MDSAP, MDR/IVDR)
- [ ] Cosmetics & Food (ISO 22716, ISO 9001, EFfCI)
- [ ] Internal Oversight (Mock Inspection, Internal Audit, CAPA Support)
3. Site Logistics
- Physical Location of Audit Site(s): (City/Country) ________________
- Preferred Timeline: [ ] Immediate (1-3 months) [ ] Planning (3-6 months) [ ] Routine/Annual
- Audit Model: [ ] On-Site [ ] Remote/Virtual [ ] Shared Audit Opportunity
4. Additional Technical Details
Please describe any specific high-risk processes or specialized requirements (e.g., Sterile Fill-Finish, Software Validation, Cell & Gene Therapy):
________________________________________
________________________________________
________________________________________
Why the ARIREX Consultation is Different:
- Direct Expert Access: Your inquiry goes straight to a senior auditor, not a sales generalist.
- Bespoke Scheduling: As an agile firm, we offer rapid response times that legacy competitors cannot match.
- Global Regulatory Fluency: We don't just find gaps; we provide the roadmap to bridge them in alignment with FDA, EMA, and WHO standards.