EXCiPACT is a not-for-profit organization that owns and manages an independent, high-quality, third-party certification scheme for pharmaceutical excipient and pharmaceutical auxiliary material (PAM) manufacturers and distributors worldwide.
EXCiPACT certification is accepted by all major stakeholders, including the EU, US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA). However, it is not a substitute for regulatory inspection, where required.
With a global network of experienced auditors, we can assess your operation against the standard and, on successful completion, approve your EXCiPACT certification.
Why choose EXCiPACT certification from SGS?
EXCiPACT certification enables you to:
- Confirm compliance with EXCiPACT GMP and/or GDP standards
- Demonstrate that your operations meet minimum GMP and/or GDP requirements for excipients
- Verify supply chain compliance, reducing the need for duplicate audits, saving you time and money
- Ensure a safer, more reliable and transparent pharmaceutical supply chain
- Reduce audit burden and cost for excipient and PAM suppliers and users
Trusted EXCiPACT certification services from a world leader
As the world’s leading certification, testing, verification and inspection company, we provide in-depth expertise in EXCiPACT GMP/GDP requirements.
The Falsified Medicines Directive in Europe places express requirements on the Marketing Authorization Holder (MAH) to assess GMP used to manufacture, as well as GDP used in distributing excipients by third parties. Organizations achieving EXCiPACT GMP/GDP certification can give clients access to their audit reports, as well as any ongoing surveillance activity, fulfilling this requirement. The FDA has similar requirements.
To discuss your EXCiPACT requirements, contact us today.
Lot 3 & Lot 4, Persiaran Jubli Perak,
Seksyen 22, 40300,
Shah Alam, Selangor, Malaysia