Third party audits provide an independent, objective assessment of a supplier's or contract manufacturer's GMP compliance and quality systems. They are essential for due diligence, supplier qualification, and ongoing vendor management. RBridge Lifesciences' founder is a BSI-certified Lead Auditor for ISO 13485 (Medical Devices) with direct experience auditing manufacturers in India, Spain, China, France, and the UK.
What We Offer
- GMP Audits of API, Intermediate, and Finished Dosage Form Manufacturers
- Supplier Qualification Audits
- QP Audits for EU Batch Release
- ISO 13485 Third Party Audits (Medical Devices)
- Audit Report Preparation and Review
- CAPA Review and Compliance Closure
- Peer Review of Audit Documentation
Our Audit Scope
- Facilities audited across India, Spain, China, France, and the United Kingdom
- Covers API manufacturers, intermediates, excipient manufacturers, and finished formulation sites
- Audit reports prepared to international standards and reviewed prior to client submission
- Auditee responses reviewed for adequacy; CAPA tracked to closure