EXCiPACT^™ – Certification for Pharmaceutical Excipients

(accredited by EXCiPACT)

Safety down to the last detail with EXCiPACT^™: with the introduction of a voluntary international certification scheme for pharmaceutical excipients, the International Pharmaceutical Excipients Council (IPEC) sent a strong signal. Since February 1st 2014 this certification is available in order to ensure good manufacturing practice (GMP) and good distribution practice (GDP) standards in the production and delivery of pharmaceutical excipients.

For Tablets and More

Pharmaceutical excipients often make up the bulk of a medicinal product. They not only determine shape, colour, odour and flavour, but also control release of the active ingredient and other properties. On average they account for 90% of the volume and weight of a product.

End-to-End Quality along the Supply Chain

The goal of EXCiPACT^™ is end-to-end quality control along the supply chain. It has been developed by industry experts, including EFCG, IPEC Europe, IPEC Americas, FECC and PQG, supported by a collaboration with the Rx360 Consortium, and is therefore recognised worldwide.

Benefits All Around

An EXCiPACT^™ certification delivers many benefits:

• Generally relevant:
  the certification can be applied to all manufacturers and suppliers of pharmaceutical excipients.
   
• Assured quality (of pharmaceuticals):
  certification based on a recognised GMP and GDP standard.
   
• Assured patient safety:
  the patient is the focus of all activities.
   
• Worldwide recognition:
  the certification is backed by EFCG, IPEC Europe, IPEC Americas, FECC, PQG and the Rx360 Consortium.
   
• Reduced time and costs:
  the effort required for the main audit and the subsequent surveillance audits is foreseeable.
   

Reaching Your Destination with ISO 9001

We have good news for all ISO 9001-certified companies: they fulfil the pre-requisite for an EXCiPACT™ certification.

USA: Equivalent to ANSI-NSF 363

No problems in the US: EXCiPACT™ is equivalent to the US standard ANSI-NSF 363, easing collaboration with overseas partners.

Accreditation for AJA Registrars

AJA Registrars fulfils the strict requirements for auditors and certification rules for auditing organisations applied by EXCiPACT™. With a certification from AJA Registrars, backed by our experience and expertise, manufacturers, suppliers and users of excipients benefit from increased safety along the supply chain which eventually leads to improved patient safety.

For more information about the pharmaceutical excipient certification please contact us!