Pharmaceutical
The role of the Pharmaceutical Quality Management Systems (PQMS) Auditor is to support the global pharmaceutical supply chain by providing value for: the auditee, the auditee’s customers and the auditor’s employer.
The PQMS auditor provides this value by providing an accurate assessment of supplier organizations’ ongoing capability to deliver products that meet the requirements of patients, health care professionals, regulatory authorities, and internal/external customers throughout the product lifecycle.
IRCA's PQMS programme is based on these reference standards:
- ICH Q10 (current edition), Pharmaceutical Quality System, plus
- ICH Q9 (current edition) Quality Risk Management
- ICH Q8 (current edition) Pharmaceutical Development
- ISO 19011 (current edition), Guidelines for auditing management systems
Note: It is the responsibility of the auditor to ensure that they have knowledge of the required GxP in which they will audit.