QUALITY FOCUS AND
SUPPLY CHAIN TRANSPARENCY

At A&C we are committed to providing services and products that meet both local and international quality and regulatory requirements. Our Quality Assurance and Quality Control teams are formed by highly skilled and qualified experts with many years of  experience in the pharmaceutical industry. Their work ensures that our compliance with all pharmaceutical standards and requirements is constantly respected.

All of our manufacturing sites have received the ISO certification and each of our Canadian manufacturing plant is an FDA registered facility. Our facilities are routinely audited by regulators, accreditation bodies and customers. A&C demonstrates a strong commitment to being highly organized, as well as being responsible in all of our activities in accordance with regulatory requirements and to sustainably meet pharmaceutical and biopharmaceutical standards. This is achieved through consistent implementation of our standard operating procedures and Quality Management System (QMS) which ensures compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

A&C is committed to practicing continuous improvement in all its operational activities, including our Quality Management System. Through a data governance policy, A&C continuously looks into opportunities of improving data integrity management using validated automated systems.

All products have a supply chain statement available upon request, and customers are notified of significant changes through A&C’s change control program. Our Quality Management System (QMS) outlines and ensures that our customers receive a product that continually meets the standards of quality, purity, safety and suitability for their manufacturing application.

Good Manufacturing Practice (GMP) 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.

GMPs are at the core of our QMS. They provide the confidence necessary in our supply of quality excipients, buffers, process solutions and active pharmaceutical ingredients. A<span class=”new-and”>&amp;</span>C’s QMS also ensures that continuous improvement across our organization is maintained, meaning that A<span class=”new-and”>&amp;</span>C will provide products meeting the most current standards required by the pharmaceutical and biopharmaceutical industries.

International Standards such as ISO are instrumental in facilitating international trade. ISO 9001:2015 Quality Management System (QMS) is an internationally recognized quality management standard implemented by over one million organizations in over 170 countries globally.

A &C previously held ISO 9001:2008 for 10 years, and is currently ISO 9001:2015 certified.

Implementing ISO Certification 9001:2015 has become an invaluable asset to A&C in enhancing customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customers, and applicable statutory and regulatory requirements. Being ISO certified also helps A&C achieve excellence in our customer service and delivery. All areas of A&C’s business fulfill their obligations and adhere to the official standards.

*A&C’s ISO 9001:2015 certified QMS manufacturing facilities are:
– Site A: 3010 rue de Baene, Montreal, QC H4S 1L2, Canada
– Site B: 20325 avenue Clark-Graham, Baie-D’Urfé, QC H9X 3T5, Canada
– Site C: Grange Business Park, Skule Hill, Fedamore, Co. Limerick, Ireland

Additional ISO Information

ISO creates documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. ISO International Standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and by increasing productivity.

ISO Certification 9001:2015, in particular, specifies requirements for a QMS when an organization:

a)  Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b)   Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer.

ISO 9001 contains eight key principles of quality management which are not auditable but do form the fundamental characteristics of quality management:

• Customer focus and customer satisfaction
• Leadership
• Involvement of people
• Process approach
• A systematic approach to management
• Continuous improvement
• Factual approach to decision-making
• Mutually beneficial supplier relationship

Benefits of ISO 9001:2015:

• Become more cost efficient
• Increase credibility and competitiveness
• Lower costs and shorter cycle times through effective use of resources
• Enhance customer satisfaction and improved customer loyalty leading to repeat business
• Increase revenue and market share obtained through flexible and fast responses to market opportunities
• Integrate and align internal processes which will lead to increased productivity and results
• Consistency in the delivery of your product or service
• Improve communication, planning and administration processes

As the first North American company to become EXCiPACT certified for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) in 2014, A&C demonstrates our commitment to meeting the global requirements for pharmaceutical excipients. The EXCiPACT Certification Scheme is a high quality, 3rd party international certification scheme for manufacturers, suppliers and distributors of pharmaceutical excipients. EXCiPACT was introduced by a consortium 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) to provide guidelines to regulate quality management in the production and marketing of pharmaceutical excipients.

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, exams, and registration process.

Being EXCiPACT certified enables A&C to demonstrate that its operations meet the minimum GMP and/or GDP requirements for excipients.

EXCiPACT benefits:

• Saves both supplier and their customers’ money
• Provided by approved third party Certification Bodies
• Reduces audit burden and cost for suppliers and users
• Supported by key regulatory bodies
• Helps excipient users identify qualified suppliers

Additional EXCiPACT information

A&C has been EXCiPACT certified for excipients for years. The GMP guidelines regulate quality management in the production and marketing of active pharmaceutical ingredients. A quality management system that meets the requirements of “good manufacturing practice” for pharmaceuticals is required for these products.

The Scheme is owned and managed by EXCiPACT asbl, Brussels and is delivered by EXCiPACT registered auditors. EXCiPACT ensures the competency of the third 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. Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors. These auditors are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry. EXCiPACT asbl is a non-profit organization that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

An ISO 9001:2015-approved excipient supplier contracts with an EXCiPACT – approved independent third party Certification Body, agrees the audit scope and standard to be used (GDP, GMP or both), and, if the audit shows compliance, the Certification Body provides them with an EXCiPACT certificate and audit report to share with their customers. Certification is valid for three years and includes annual surveillance audits verifiable on the EXCiPACT website.

A&C has been FDA registered for pharmaceutical ingredient manufacturing since 2014 and had a successful FDA audit in 2018. Each of A&C’s Canadian manufacturing site is an FDA registered facility. A&C has also held a Health Canada Drug Establishment License (DEL) for manufacturing, labelling, testing and distribution of Active Pharmaceutical Ingredients since 2015. A DEL is a licence that allows licensable activities to be conducted in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations. The buildings where these activities occur in Canada must undergo inspections to show compliance with GMP standards. All Canadian fabricators, packagers/labellers, testing laboratories, importers, wholesalers and distributors of active ingredients must meet Good Manufacturing Practices (GMP) regulatory requirements. A&C is compliant with all of these requirements.

Additional Health Canada Information

The quality of active ingredients in a drug has a direct effect on the safety and efficacy of that drug. Regulating active ingredients will help increase the quality and safety of drugs for consumers, and will strengthen the pharmaceutical drug supply system. Health Canada works with other levels of government, health care professionals, patient and consumer interest groups, research communities and manufacturers to minimize the health risk factors and maximize the safety provided by the regulatory system for these products.

Some of Health Canada’s features include:

• Improving the regulatory review of drugs and devices
• Drug and Health Product Register
• Get recalls and safety alerts
• Prescription Drug List
• Advisories, Warnings & Recalls
• Drug Product Database
• Licensed Natural Health Products Database
• Contact Drugs and Health Products Resources

Additional FDA Information

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices, and by ensuring the safety of America’s food supply, cosmetics and products that emit radiation. The FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public acquire the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

The FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Those inspected also include vaccine and drug manufacturers. The FDA does have the authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations. Manufacturers must also prove that they are able to make the drug product according to federal quality standards. A&C has always proven to be compliant with the required standards and each of A&C’s Canadian facilities is an FDA registered facility. FDA approval of a drug means that data on the drug’s effects have been reviewed by the CDER (the FDA’s Centre for Drug Evaluation and Research) and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

The drug approval process takes place within a structured framework that includes:

• Analysis of the target condition and available treatments
• Assessment of benefits and risks from clinical data.
• Strategies for managing risks.