ICH Q10 Pharmaceutical Quality System , Section G provides guidance on the Management of Outsourced Activities and Purchased Materials.
“Pharmaceutical companies are responsible for ensuring processes are in place to assure the control of outsourced activities and quality of purchased materials.”
- Assess PRIOR to outsourcing operations or selecting material suppliers the suitability and competence of the supplier/vendor. (AUDITS)
- Define responsibilities and communication processes for quality related activities. (QUALITY AGREEMENTS)
- Monitor and review the performance of the vendor/supplier, and identify essential improvements. (SUPPLIER MONITORING) (SUPPLIER CORRECTIVE ACTION PROCESS)
- Monitor incoming ingredients and materials, ensure they are from approved sources using agreed upon supply chain. (AUDITS)
Quality Audit Consulting (QAC) can help you manage your supplier/vendor audit schedule.
QAC can help you implement a Quality Agreement with your suppliers and vendors.
QAC can act as your supplier manager and ensure your supplier audit schedule is completed on time.
QAC can complete your scheduled audits with qualified, experience auditors.
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Contact us through our website at QualityAuditConsulting.com