Value proposition

  • Safe, reliable, transparent pharmaceutical supply chain
  • Cost savings by reducing the audit burden for both customers and supplier without sacrificing quality

Benefits

Benefits for Excipient Suppliers and Users

  1. Provides the suppliers’ customers (users) with a high quality, reliable and credible 3rd party certificates and audit reports for their quality management systems to help them meet their product regulatory requirements for excipients having the same acceptance and value anywhere in the world
  2. Ease of Access: Certification from EXCiPACT-registered 3rd party certification organisations (or Certification Bodies)
  3. Evolutionary: builds on existing ISO 9001 certification and the well-known IPEC-PQG guides for GMP and the PQG guide for GDP
  4. Simple: easy to understand and apply for all stakeholders
  5. Inclusive: applicable to all pharmaceutical excipient manufacturers, suppliers and distributors whether they have or do not have ISO 9001 certification
  6. Permits the supplier to proactively demonstrate commitment to cGMP and cGDP in the manufacture and supply of their pharmaceutical excipients
  7. Reduces the audit burden/time for both suppliers and users saving supply chain costs without compromising product quality
  8. Provides users with sufficient documentation to satisfy the regulators
  9. Final certification approval by an independent panel of experts who assess it meets the needs and expectations of the supplier, users and regulators

Benefits for Certification Bodies and Auditors

  • Provides them with new worldwide business opportunities based on the audit and certification of pharmaceutical excipient manufacturers, suppliers and distributors using the EXCiPACT Certification Scheme

Products & Services

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Typical Cost Savings

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