GMP — Good Manufacturing Practice
Strengthening Supply Chain Integrity Through Senior Technical Oversight
In today's global pharmaceutical and biotechnology environment, a GMP audit is not a procedural formality—it is the backbone of patient safety, product quality, and market continuity. 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.
We perform rigorous facility evaluations covering APIs, excipients, drug products, and aseptic/sterile manufacturing, ensuring that every operational reality aligns with global regulatory expectations.
Core Technical Audit Focus
Facility & Operations Control
- Aseptic & Sterile Manufacturing: Specialized oversight for cleanroom classifications (Grade A-D), media fills, and environmental monitoring (EM) strategies in alignment with EU GMP Annex 1 (2022).
- Critical Utilities: Technical assessment of HVAC systems, Water for Injection (WFI), and Pure Steam systems to ensure state-of-the-art contamination control.
- Advanced Therapies (ATMPs): Specialized auditing for Cell & Gene Therapy facilities, focusing on closed systems, viral safety, and chain of identity (COI).
Science-Based Validation
- Process & Cleaning Validation: Review of worst-case scenario justifications, health-based exposure limits (HBEL), and residue recovery studies.
- Data Integrity & ALCOA+: Sophisticated verification of electronic records and audit trails in both the manufacturing suite and QC laboratories (21 CFR Part 11).
- Equipment Qualification: URS, DQ, IQ, OQ, and PQ verification for high-complexity production equipment.
Regulatory Fluency & Standards
Our auditors apply a multi-jurisdictional approach, ensuring your facility is ready for any global health authority:
- United States: FDA 21 CFR Parts 210/211 (Finished Drugs) & Part 11 (Digital Records).
- European Union: EudraLex Volume 4, including Annex 1 (Steriles), Annex 11 (Computerized Systems), and Annex 15 (Validation).
- Global Standards: ICH Q7 (APIs), ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and PIC/S GMP Guide.
- WHO: Technical Report Series for pharmaceutical production and quality control.
The ARIREX Advantage
- Senior Technical Experts: All audits are performed by industry veterans with local language fluency and global regulatory mastery.
- Risk-Based Methodology: We prioritize findings that impact patient safety and product efficacy, providing a clear roadmap for remediation.
- Shared Audit Opportunities: Reduce compliance costs through our collaborative shared platform, mitigating audit fatigue for your suppliers.