Since the foundation of our company in 1966, quality has been our main focus and one of the core components of A&C’s brand promise. We were the first North American company to become EXCiPACT GMP and GDP certified. A&C has now been GMP certified for excipients for years and we continue to demonstrate our commitment to meeting GMP standards and all the global requirements for pharmaceutical excipients. All of our GMP manufacturing facilities are routinely audited by accreditation bodies, regulators and customers to certify GMP compliance.
We acknowledge the importance of GMP compliance for our clients, and all of our products and services are developed to meet our customers’ expectations in terms of high quality standards. We are committed to providing services and products that strictly adhere to the required GMP standards. GMP standards are also essential for all of A&C’s services, including GMP custom ingredient development, GMP manufacturing and GMP custom packaging.
The GMP guidelines regulate quality management in the production and marketing of active pharmaceutical ingredients. These products require a Quality Management System that meets the GMP standards. We utilize one of the world’s leading automated QMS, named Master Control, which helps achieve our quality and compliance goals. We sustainably meet pharmaceutical and biopharmaceutical standards through the consistent implementation of our standard operating procedures (SOPs) and Quality Management System, which ensure GMP compliance.
The scheme comprises the following:
- GMP Standards for excipients (either EXCiPACT GMP annex to ISO 9001:2015, or NSF/IPEC/ANSI 363-2014 GMP- includes requirements of ISO 9001:2015).
- GDP Standard for excipients (EXCiPACT GDP annex to ISO 9001:2015).
- Certifying Body quality system definition and qualification process.
- Auditor Competency definition, training course, exam and registration process.