— Global Pharmaceutical, Biologics & Preclinical GxP Auditing
Strengthening Supply Chain Integrity Through Senior Technical Oversight & Global Regulatory Fluency
In today’s global pharmaceutical and biotechnology environment, a GxP audit is not a procedural formality—it is the backbone of patient safety, product quality, and market continuity. With increasingly complex supply chains spanning multiple continents and evolving health authority expectations, organizations require an auditing partner with uncompromising technical precision and global regulatory mastery. Arirex provides deep dive, high fidelity audits performed by senior industry experts who understand the language of the laboratory and the requirements of regulators worldwide.
Our Audit Scope & Technical Depth
GMP — Good Manufacturing Practice
- We perform rigorous facility evaluations covering APIs, excipients, drug products, and aseptic/sterile manufacturing.
- Inline references: EU GMP Annex 1 (2022), FDA 21 CFR 210/211, PIC/S GMP Guide, ICH Q7 (API GMP).
Biologics & Advanced Therapies (ATMPs)
- Audits include viral clearance, upstream/downstream bioprocessing, aseptic isolator systems, CGT manufacturing, and cold chain controls.
- Inline references: EU Annex 2 (Biologics), FDA Guidance for CGT Chemistry & Manufacturing.
GDP — Good Distribution Practice
- We verify global distribution channels, warehouse controls, and cold chain stability using risk based sampling.
- Inline references: EU GDP 2013/C 343/01, WHO TRS 1025 Annex 7.
GCP & GVP — Clinical & Safety Oversight
- Clinical site and CRO audits ensure data integrity and protocol compliance.
- Inline references: ICH E6 (R2/R3), ICH E2A, ISO 14155:2020, FDA 21 CFR 11. EMA GVP Modules.
GLP — Preclinical Laboratories
- Audits of toxicology, pharmacology, and analytical labs supporting IND/IMPD submissions.
- Inline references: OECD GLP Principles, FDA 21 CFR 58.
Arirex Audit Methodology
- Risk Based Framework: Integrated with ICH Q9 & PIC/S guidance.
- Observation Categorization: Critical, major, minor with CFR/Annex citations.
- Deep QMS Analysis: Deviations, OOS, change control, investigations.
- CAPA Assessment: Focus on root cause + effectiveness validation.
- Executive Summary for Management: Clear, actionable insights.
Why Choose Arirex?
- Global regulatory fluency across the U.S., EU, Asia, LatAm, Africa.
- Senior level auditors only — no junior staff.
- Shared Audit Models to optimize your compliance budget.
- Independent, unbiased technical insight for robust decision making.
Regulatory References
- FDA: 21 CFR Parts 210, 211, 11, 58
- EU: EudraLex Vol. 4, Annex 1 (2022), Annex 2
- ICH: Q7, Q8, Q9, Q10; E6; E2A
- WHO TRS 1025 Annex 7
- OECD GLP Principles
- PIC/S GMP Guide