GMP Vendor Audits
Service Overview
Our comprehensive Good Manufacturing Practice (GMP) audits ensure compliance across global markets such as the EU, USA, India, China, Japan, Korea, Brazil, and more. Qgenyx carries out a complete chain of audits which assures product safety and quality to clients across the globe for Finished Products, APIs, Intermediates and Key Starting Materials (KSMs). Qgenyx has a team of Auditors who are accredited with various certifications including APIC/CEFIC/ASQ CQA/IRCA Qgenyx conducts qualification of the manufacturing sites in accordance with ICH Q7, EudraLex Volume4; Code of Federal Regulations 21 CFR Part 11; and PIC/s Guide to Good Manufacturing Practice for Medicinal Products, January 2017.
Scope Includes
- Quality Management & Documentation
- CAPA, Change Control, Product Quality Review (PQR)
- Storage & Distribution Facilities
- Supplier and Risk Management
- HACCP, Allergen & Food Safety (for Dietary Supplements)
Bulk Audits / Shared Audits
Qgenyx also offers unique business models whereby manufacturers of APIs, KSMs, Excipients can significantly reduce their load of Third Party Audits and consequent CAPAs. Get in touch with us now and explore the unique and innovative Bulk Audits or Shared Audits business model.
Why Choose Us
- Experienced auditors with decades of GMP auditing across regulated markets
- Impartial, detailed audit reports ready for QP declarations
- Additional support through training and compliance advisory
Key Benefits
- Comprehensive GMP compliance verification
- Detailed audit reports for regulatory submission
- Risk mitigation and quality assurance
- Expert auditor support and guidance
Ready to Get Started?
Contact our expert team to discuss your GMP audit requirements.
Contact Our Team