EXCiPACT Certification

Pharmaceutical excipient certification, through Excipact™ accreditation, is a voluntary international scheme to provide independent third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients worldwide.
Excipact certification enables you to demonstrate that your operations meet the minimum Good Manufacturing Practice (GMP) and/or Good Distribution Practice (GDP) requirements for excipients. It also enables you to verify the compliance of other actors in the supply chain, reducing the need for duplicate audits saving you both time and money. Accepted by all major stakeholders including relevant authorities globally - European Union (EU), US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Authority (MHRA) - it is not however 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, giving access to:
A safer, more reliable and transparent pharmaceutical supply chain
Cost savings by reducing the audit burden for both customer and supplier without sacrificing quality
The Falsified Medicines Directive in Europe places express requirements on Marketing Authorization Holders (MAH) to assess the GMP used in the manufacture and GDP used in the distribution of excipients by third parties. Organizations achieving Excipact certification can give their clients access to their audit report, as well as any ongoing surveillance activity, fulfilling this requirement. There are similar requirements from the FDA in the USA.