Table of contents
What is a Third-Party Audit?
A third-party audit is an independent assessment carried out by a specialized external body – such as GCB – to verify whether suppliers, subcontractors, or manufacturing sites meet legal requirements, industry standards, and internal client procedures.
Step-by-Step Audit Process
- Initial document review
- Site visit and infrastructure inspection
- Personnel interviews and procedural review
- Evaluation of quality documentation
- Audit report and recommendations
Scope of a Third-Party Audit
The audit involves a comprehensive review of critical areas of the evaluated organization’s operations:
- Manufacturing infrastructure – compliance with technical and sanitary requirements
- Systems and installations – e.g. water purification, HVAC, lighting, ventilation
- Hygiene program – cleaning, disinfection, hand hygiene, protective clothing procedures
- Production processes – from raw materials to packaging, including filling and labeling
- Quality control systems – inspection of material acceptance, in-process and final controls
- Storage and transportation – conditions, traceability, batch management
- Document management – logs, procedures, inspection reports, corrective and preventive actions
- Staff training – compliance of competencies with assigned roles, training records
- Regulatory compliance – including Regulation (EC) No 1223/2009, ISO 22716, and retailer requirements
How to Prepare Your Facility
- Ensure compliance with ISO 22716
- Verify that all documentation is complete and up to date
- Train staff on GMP procedures
- Prepare key areas for inspection – hygiene, traceability, storage
Common Errors and Non-Conformities
- Incomplete training documentation
- Gaps in batch traceability
- Insufficient cleaning and disinfection protocols
- Mismatch between documented and actual procedures
Documentation Required for Audit
- GMP procedures
- Cleaning and quality control records
- Raw material safety data sheets
- Previous audit reports
- Employee competency matrices
Third-Party vs Internal Audits
Internal audits serve as a self-assessment tool. Third-party audits provide independence, greater credibility, and can be leveraged in business relationships.
Why Choose GCB?
As an independent Notified Body, GCB conducts third-party audits in accordance with principles of objectivity, impartiality, and full compliance with current legal standards. Each audit concludes with a detailed report identifying strengths and, where necessary, areas of non-compliance. Audits can be performed cyclically, as one-off evaluations, or as part of a contractor qualification system.
