(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.
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.
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.
An EXCiPACT™ certification delivers many benefits:
We have good news for all ISO 9001-certified companies: they fulfil the pre-requisite for an EXCiPACT™ certification.
No problems in the US: EXCiPACT™ is equivalent to the US standard ANSI-NSF 363, easing collaboration with overseas partners.
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!