EXCiPACT certification

The pharmaceutical industry is one of the most strictly regulated sectors globally. In the production of medicinal products and over-the-counter drugs, excipients play a crucial role as essential component. These excipients are also required to meet the rigorous standards of GMP/GDP/GWP audits, ensuring the quality of the final pharmaceutical products.

EXCiPACT has thus emerged as an aligned certification scheme for the industry. Eurofins Assurance is an approved Certification Body to support the excipients industry’s compliance requirements.

Purpose of EXCiPACT

To mitigate audit fatigue and the costs associated with repeated GMP, GDP and GWP audits for excipient users and suppliers, industry stakeholders have come together to establish EXCiPACT. This initiative aims to enhance transparency in excipient quality while managing a harmonized certification scheme that offers broader benefits to the industry.

Coverage of EXCiPACT certification

The EXCiPACT certification covers three standards, all aligned to ISO9001:2015, to suit different supplying roles in the industry:

Good Manufacturing Practice (GMP) standard for excipients, designed for manufacturers of excipients
Good Distribution Practice (GDP) standard for excipients, designed for distributors of excipients
Good Warehousing Practice (GWP) standard for excipients, designed for warehouses for excipients

Process of EXCiPACT certification

EXCiPACT certificates remain valid for a period of three years. For new suppliers or customers seeking re-certification, the following process will apply:

1. Select EXCiPACT-registered Certification Body and provide necessary information, including audit scope, operation scale and organisational details so Certification Body can respond with quotation and audit plan.
2. Customer and Certification Body confirm certification agreement.
3. Certification Body runs documentation review to assess preparedness and the documented system.
4. The Certification Body conducts an on-site detailed audit to assess the customer’s performance against all requested scope(s). After the site audit, the auditor prepares a report that contains assessment details and any identified non-conformities, which are then reviewed by the Certification Body to make a certification decision.
5. Once the Certification Body decides the certification is a successful completion, certificate and audit report will be sent to the customer. Certification result and customer’s information will also be shared with EXCiPACT for Certificate Holders listing.
6. Surveillance audit is required once a year throughout the 3-year cycle.

Reason for choosing Eurofins Assurance

Choosing Eurofins Assurance for your EXCiPACT certification brings a seamless and comprehensive audit experience.

As an approved Certification Body, our team of seasoned auditors brings extensive expertise and up-to-date knowledge of pharmaceutical excipient regulations and best practices. With over 15 years of experience in pharmaceutical GxP audits, you can rely on our deep industry insights. We are dedicated to excellence and client satisfaction, supporting you on your path toward environmental sustainability and continuous improvement.

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