Around the globe, the concerns of consumers and governments are putting pressure on the Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) of pharmaceutical manufacturers, as they try to comply with international guidelines, standards and regulations. This pressure affects all operators in the pharmaceutical supply chain, including those involved in the manufacture of pharmaceutical excipients.
To protect patients and reduce risk, legislators and regulators continue to address weaknesses in the application of GMP and GDP for pharmaceutical excipients.
Pharmaceutical excipients are those substances intentionally included in the drug delivery system that are not the active ingredient. Just like the active ingredient, they must be proven safe for the consumer. Quality and purity are vital, a point reinforced by the tragic results seen following fraudulent claims of pharmaceutical raw material purity.
To protect patients and reduce risk, legislators and regulators continue to address weaknesses in the application of GMP and GDP for pharmaceutical excipients. If appropriate quality standards are not followed, excipients may become a hazard to patient safety. It is important, therefore, for manufacturers to have robust systems in place to ensure quality and purity of excipients.
A common requirement of many pharmaceutical regulations is the need for the drug product manufacturer, the excipient’s user, to have a good understanding of the excipient manufacturers management systems, both GMP and GDP. Inevitably, this can result in the excipient manufacturer’s facilities being subject to unsustainable numbers of audits. To reduce this burden, authorities have clearly stated excipient users can utilize third-party audit organizations to reduce this impact, in terms of time and resources on both supplier and user.
‘Authorities have clearly stated excipient users can utilize third-party audit organizations to reduce this impact, in terms of time and resources on both supplier and user.’
EXCIPACT
Based on the widely accepted IPEC-PQG GMP and the IPEC GDP Guides for pharmaceutical excipients, EXCiPACT is a certification scheme dedicated to excipient suppliers. It was developed by industry experts from the European Fine Chemical Group (EFCG), International Pharmaceutical Excipients Council (IPEC) Europe, IPEC-Americas, European Association of Chemical Distributors (FECC), and Pharmaceutical Quality Group (PQG), and first published in 2012 with a revised version in 2017.
EXCiPACT standards (GMP and GDP) provide demonstrable evidence that the pharmaceutical excipient supplier has developed, documented, and implemented robust processes for managing the production and/or distribution of his products. It shows compliance with customer, local, national and international GMP and GDP requirements for pharmaceutical grade excipients, and it helps ensure patient safety while improving supplier quality assurance. In addition, it will minimize overall supply chain costs.
Auditing against EXCiPACT standards is conducted by a third-party audit organization, or Certification Body. After the EXCiPACT standard (GMP or GDP) has been applied by the manufacturer or distributor of pharmaceutical grade excipients, they will apply for certification through the Certification Body. Certification demonstrates consistency and quality in all aspects of production and distribution, and shows compliance with customer, local, national and international GMP and GDP requirements.
Certification signifies the commitment of the organization to complying with appropriate regulations and demonstrates to legislators, regulators and potential users that all materials being produced in their sites are safe.
EXCIPACT STANDARDS 2017
The 2017 update to the EXCiPACT Standards brings them into line with ISO 9001:2015, ISO/IEC 17021, and US National Standard NSF/IPEC/ANSI 363-2016 – Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. It reflects the changes brought in by these standard’s latest editions, including the structural updates.
Many excipient suppliers already apply ISO 9001 in their operations. This standard provides a framework from which the supplier can build and develop suitable management systems. It forms the basis of the latest version of EXCiPACT for GMP and GDP as two annexes to ISO 9001:2015. ISO 9001 is a prerequisite for organizations applying for EXCiPACT certification, although stakeholders can be assessed to ISO 9001:2015 and the EXCiPACT™ GMP or GDP annex at the same time.
If the supplier does not hold ISO 9001 certification, an alternative route is adherence to US National Standard NSF/IPEC/ANSI 363-2016 – Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. This standard is also based on the original IPEC-PQG GMP Guide 2006.
WHY CERTIFY TO EXCIPACT?
Certification signifies the commitment of the organization to complying with appropriate regulations and demonstrates to legislators, regulators and potential users that all materials being produced in their sites are safe.
SGS has recently certified four sites operated by Air Liquide France Industries as complying with the requirements of the EXCiPACT GMP standard. As an internationally recognized EXCiPACT Certification Body, the Air Liquide France Industries’ accreditation is just one numerous success audits SGS has performed on excipient supplier facilities around the world.
About SGS
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