Preparing for EXCiPACT Certification: Typical Findings

EXCiPACT is an ISO 9001-based GMP and GDP certification scheme developed for manufacturers and distributors of pharmaceutical excipients. Audits are carried out by independent auditors registered with the scheme. Although the transition may look easy for a company that already holds ISO 9001, certain topics come up as findings again and again.

Finding areas we see most often

• Supplier qualification: missing risk-based evaluations and periodic re-evaluation records for critical raw material suppliers.
• Change control: no assessment of whether changes to processes, equipment or suppliers must be notified to customers.
• Traceability: batch traceability from raw material to shipment breaking down, especially at repackaging and relabelling steps.
• Deviations and CAPA: superficial root cause analyses and no verification of CAPA effectiveness.
• Data integrity: missing user access control and audit trail reviews on laboratory instruments.
• Premises and equipment: measures against cross-contamination and foreign matter not being justified.

Our recommendations for preparation

Before the certification audit, carry out an independent gap analysis against the scheme's requirements and prioritise the findings by risk. Review the processes that govern supplier and customer relationships (agreements, notifications, complaints). Finally, make sure your team is ready with a mock audit that simulates real audit conditions.

When planned well, EXCiPACT is not just a certificate but a strong trust tool that reduces the number and burden of customer audits.