GMP — Good Manufacturing Practice
Ensuring Product Quality, Safety & Regulatory Compliance in Manufacturing
In the pharmaceutical and biotech industries, GMP is the foundational requirement for product safety and patient trust. Arirex provides senior technical oversight and high-fidelity audits to ensure your manufacturing processes, facilities, and quality systems meet global expectations.
Our GMP Audit Scope
Facility & Manufacturing Oversight
- Rigorous evaluations of APIs, Excipients, Drug Products (finished dosage forms), and Sterile/Aseptic manufacturing environments.
- Standards: EudraLex Vol. 4 (EU), FDA 21 CFR Parts 210/211 (US), PIC/S GMP Guide, ICH Q7 (APIs).
Biologics & Advanced Therapies (ATMPs)
- Specialized audits for viral clearance, upstream/downstream bioprocessing, aseptic isolator systems, Cell & Gene Therapy (CGT) manufacturing, and cold chain controls.
- Standards: EU GMP Annex 1 (Steriles), Annex 2 (Biologics), FDA Guidance for CGT Chemistry & Manufacturing.
Technical System Evaluations
- Deep-dive reviews of environmental monitoring (EM) programs, facility hygiene, equipment calibration/qualification, and media fill performance.
- Assessment of cleaning validation, process validation, and utility systems (Water for Injection, HVAC).
Arirex GMP Methodology
- Risk-Based Framework: Integrated with ICH Q9 & PIC/S guidance to prioritize high-risk process observations.
- Data Integrity Focused: Every GMP audit includes a review of ALCOA+ principles in the manufacturing suite and QC laboratory.
- Actionable Reporting: We don't just find gaps; we categorize findings into Critical, Major, and Minor with a clear roadmap for remediation.
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