Montreal - A & C
Custom manufacturing of excipients, buffers and process solutions for our global client base has allowed A&C to rapidly resolve our customers’ challenges in either the preclinical phase, in clinical trial phases I, II or III, or in commercial finished drug manufacturing. With over five decades of experience as an excipient manufacturer, A&C has the technical, regulatory and quality expertise to resolve a wide variety of our customers’ GMP issues by providing a wide range of tailored solutions, including GMP custom manufacturing of excipients and raw materials.
A&C has been successfully custom manufacturing a multiplicity of raw materials including solvents, preservatives, lubricants, binders, antioxidants, process solutions and buffers and a select number of APIs which are all manufactured under GMP and meet the required governing monographs (USP/NF/EP/BP/JP) or multi-compendial grade.
All products also enter into A&C’s Quality and Supply Chain management system. Since quality, transparency and change control are crucial for us and for our clients, all of our processes are designed to keep customers appropriately notified of significant changes. To further limit our customers’ risk, A&C works with multiple raw materials suppliers to have secondary sources approved where possible.
Quality Assurance and Quality Control
Since inception, quality has been our main focus and one of the core components of the legacy A&C organization and the Montreal facility. A&C's Montreal organization was the first North American company to become EXCiPACT GMP and GDP certified. The facility 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 our 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.