Leaders in Quality:
A&C, your global GMP partner, has been servicing the Life Science industry since 1966.
Through A&C’s sustained focus on meeting the most stringent regulatory requirements, we continue to meet and exceed the needs of pharmaceutical and biopharmaceutical manufacturers. As the first North American company to become EXCiPACT GMP and GDP certified, A&C demonstrates our commitment to meeting the global requirements for pharmaceutical excipients.
A group of industry experts from the European Fine Chemicals Group (EFCG), the International Pharmaceuticals Excipients Council (IPEC) Europe, IPEC Americas, the European Association of Chemicals Distributors (FECC), and the Pharmaceutical Quality Group (PQG), worked together as a consortium on the development of a certification scheme for pharmaceutical excipient suppliers – EXCiPACT.
The EXCiPACT Certification Scheme is a high quality, 3rd party international certification scheme for manufacturers, suppliers and distributors of pharmaceutical excipients. The Scheme is owned and managed by EXCiPACT asbl, Brussels and is delivered by EXCiPACT- approved 3rd party Certifying Bodies employing EXCiPACT- registered auditors.
EXCiPACT ensures the competency of the 3rd party auditors and the frameworks in which they operate. It will ensure patient safety through supplier quality, while minimizing the audit burden and overall costs for assessing the excipient supply chain without sacrificing quality.
- GMP Standards for excipients (either EXCiPACT GMP annex to ISO 9001:2008, or NSF/IPEC/ANSI 363-2014 GMP- includes requirements of ISO 9001:2008)
- GDP Standard for excipients (EXCiPACT GDP annex to ISO 9001:2008)
- Certifying Body quality system definition and qualification process
- Auditor Competency definition, training course, exam, and registration process
A&C prides itself on being known as a company that provides full transparency in the supply chain and strictly adheres to pharmaceutical supply chain best practices. Our Quality Management System outlines and ensures our customers receive a product that continually meets the quality, purity, safety and suitability for their manufacturing application.
cGMP processes and documentation control begin with incoming inspection, identity and in-house testing. These records become an integral part of the documentation chain of traceability that is maintained until the final product reaches the customer.
Customers are notified of significant changes through a strict change control program.
Good Manufacturing Practices (cGMPs) are at the core of our quality management system. cGMPs provide the confidence necessary in our supply of the highest quality excipients, process solutions, and active ingredients. A&C’s quality management system also ensures that continuous improvement across our organization is maintained. Continuous improvement ensures A&C will provide products meeting the most current standards required by the pharmaceutical and biopharmaceutical industries.