Our dedicated Quality Assurance Unit provides an audit program which covers the requirements of the regulatory authorities in relation to the good practices that apply to the highly regulated pharmaceutical industry. Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice quality systems are applied throughout our different services, which combined with our level of expertise in process optimization, allows us to stay ahead of ever-changing requirements.
Our Quality Assurance auditors are fully experienced in GLP, GCP, GMP and actively involved within the Canadian and international Quality community to be abreast of the latest industry and regulatory trends.
The QA team also possesses a wealth of experience in successfully managing, coordinating and hosting regulatory routine inspections including FDA, Health Canada, ANVISA, ANSM, MHRA, AGES, AEMPS, and SCC.
Other responsibilities also include:
- Internal facility and procedural inspections and study audits to assure management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with protocols, SOPs, applicable guidelines and regulations
- Management of our supplier qualification program
- Management of the revision and distribution of SOPs
- Coordination of all client audits
- Management of Archives