Our quality program is made up of two distinct functions: Quality Assurance and Quality Control. The Quality Assurance team is responsible for making sure that all parts of the GMP manufacturing process are executed according to the proper procedures. They are also responsible for our compliance with cGMP practices, ISO 9001 regulations, and governing body certifications and inspections. The Quality Control team ensures that the products leaving our facility meet all the applicable specifications.
The A&C Bio Buffer facility in Ireland is ISO 9001:2015 certified and is state-of-the-art designed to meet the requirements of GMP and GDP. A&C’s Canadian manufacturing sites are EXCiPACT certified.
The EXCiPACT Certification Scheme is a high quality, third 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 third party Certified Bodies employing 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.
OUR PROFESSIONAL PRIORITIES
Due to the fact that many of the products we manufacture are customer specific, a stability testing plan is approved with each customer. In general, the initial three manufacturing validation lots will be used to establish long-term product stability. The storage requirements based on stability testing and industry norms will be established.
We work with globally recognized suppliers of packaging materials. We are open to customer supplied or specified packaging. The packaging specification will be established and approved.
A dossier of supporting documentation including residual solvents statement, cGMP commitment statement, BSE/TSE, MSDS, allergen statement, packaging information sheet, non GMO statements, customer vendor questionnaire and any other document that is required to meet customer regulatory requirements will be established.
A&C Bio Buffer 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 process solutions, buffers and custom liquid blends. A&C’s quality management system ensures that continuous improvement across our organization is maintained. Continuous improvement also ensures A&C will provide products meeting the most current standards required by the pharmaceutical and biopharmaceutical industries.
SAFETY STOCKS & DELIVERY
Safety stocks can be held at our GDP warehouse for individual customers once annual volumes are identified. The location of A&C Bio Buffer site in Limerick is ideal for holding safety stocks for our customers due to its close proximity to the pharmaceutical and biopharmaceutical hubs.