ARIREX — Auditing Services
Independent Audits. Inspection-Ready Results.
ARIREX conducts independent GxP audits, supplier qualifications, and mock regulatory inspections across the full regulated product lifecycle — from raw materials to finished product and distribution. Every audit is scoped, executed, and reported against the standards your regulators actually enforce.
Our Auditing Practice Areas
ARIREX's auditing practice covers twelve distinct areas across the regulated manufacturing and distribution lifecycle. Whether you need a single supplier qualification audit or a full system-based GxP audit ahead of a regulatory inspection, our auditors bring direct industry experience — not just checklist familiarity — to every engagement.
1. Pharmaceutical & Biologics GMP Manufacturing Audits
Facility, process, and quality-system audits against US FDA 21 CFR Parts 210/211, Health Canada GMP Guidelines (GUI-0001), EU GMP (EudraLex Volume 4), and the PIC/S GMP Guide, with biologics-specific considerations aligned to ICH Q5/Q6. Covers manufacturing operations, batch records, environmental monitoring, and change control.
Ideal for: drug manufacturers, biologics developers, and CDMOs preparing for a routine or pre-approval inspection.
2. Active Pharmaceutical Ingredient (API) Audits
GMP audits of API manufacturers against ICH Q7, Health Canada API GMP expectations, US FDA, and EU GMP Part II — covering starting materials, process validation, and impurity control strategy.
Ideal for: finished-product manufacturers qualifying or re-qualifying an API supplier.
3. Finished Pharmaceutical Product Audits
Batch release, quality control laboratory, and finished-dosage manufacturing audits against 21 CFR 211, Health Canada GUI-0001, and EU GMP Part I.
Ideal for: brand and generic manufacturers preparing for product launch or routine surveillance inspection.
4. Excipient Manufacturer & Supplier Audits
Audits against the IPEC-PQG GMP Guide for Pharmaceutical Excipients and supplier qualification expectations under Health Canada and US FDA frameworks.
Ideal for: manufacturers building or maintaining an excipient supplier qualification program.
5. Packaging & Labelling Audits
GMP packaging and labelling control audits, covering artwork control, line clearance, and traceability requirements under 21 CFR 211 Subpart G and Health Canada GMP expectations.
Ideal for: manufacturers and contract packagers managing artwork, serialization, or labelling change control.
6. Distribution (GDP) Audits
Good Distribution Practice audits against the EU GDP Guidelines (2013/C 343/01) and Health Canada GUI-0069, including cold-chain and temperature-mapping validation review.
Ideal for: distributors, wholesalers, and logistics providers handling temperature-sensitive regulated products.
7. Medical Device & IVD Audits
QMS and process audits against ISO 13485:2016, US FDA 21 CFR 820 (Quality System Regulation), the EU Medical Device Regulation (MDR) 2017/745, and Health Canada Medical Devices Regulations (SOR/98-282).
Ideal for: device and IVD manufacturers preparing for certification, CE marking, or FDA/Health Canada inspection.
8. Cosmetics Audits
GMP audits against ISO 22716:2007, Health Canada Cosmetic Regulations, and the EU Cosmetics Regulation (EC) No 1223/2009.
Ideal for: cosmetics manufacturers and brand owners managing supplier or contract manufacturer oversight.
9. Food Industry Audits
Food safety system audits against Health Canada's Safe Food for Canadians Regulations (SFCR), US FDA FSMA (21 CFR 117), and ISO 22000.
Ideal for: food and beverage manufacturers and co-packers managing regulatory or customer-driven audit requirements.
10. Pharmacovigilance (GVP) Audits
Drug safety system audits against EU GVP Modules, Health Canada adverse reaction reporting requirements, and US FDA 21 CFR 314.80/600.80.
Ideal for: marketing authorization holders and drug safety departments assessing case-processing and reporting-timeline compliance.
11. Internal Audit & Mock Regulatory Inspections
Simulated FDA, Health Canada, and EMA-style inspections, gap assessments, and CAPA-readiness reviews — designed to expose weaknesses before a real regulator does.
Ideal for: any regulated organization preparing for an upcoming inspection or strengthening its internal audit program.
12. QMS Audits per ISO 9001:2015
Full clause-by-clause Quality Management System audits against ISO 9001:2015, applying risk-based thinking and the Annex SL high-level structure.
Ideal for: organizations maintaining or pursuing ISO 9001 certification, or benchmarking their QMS ahead of a customer or regulatory audit.
Why ARIREX for Auditing
Practitioner-led, not checklist-led
Our auditors have held quality leadership and lab management roles inside the industries they now audit.
Global standards, applied locally
Every audit is scoped against the specific regulator(s) relevant to your market: US FDA, Health Canada, EU/EMA, MHRA, or a combination.
Actionable reporting
Findings are written to support real CAPA closure, not just compliance box-checking.
Our Auditing Process
Scope
Defining audit boundaries, regulatory standards (GMP, GDP, ISO), and objectives.
Assign
Matching a certified lead auditor with specific technical and industry expertise.
Prepare
Reviewing pre-audit records, agendas, and establishing clear communication.
Execute
Conducting on-site/remote checks, interviews, and detailed document reviews.
Report
Delivering a detailed audit report with precise findings, gaps, and actions.
Follow-up
Supporting CAPA tracking, evidence resolution, and final compliance sign-off.
Ready to scope your audit?
Book a free 30-minute consultation and we'll help you define the right audit type, standard, and timeline for your organization.
Book a Consultation