Algorithme Pharma is committed to the provision of accurate, rapid and reliable results. 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 and Good Laboratory Practice quality systems are applied throughout our different services.
Our Quality Assurance audits ensure that we maintain our excellent track record and continue to operate to the standards required by the regulatory authorities. Our Quality Assurance auditors are fully experienced in GLP and GCP standards.
The QA Unit has a wealth of experience in successfully managing, coordinating and hosting frequent regulatory routine inspections (e.g. FDA, Health Canada, ANVISA, ANSM, MHRA, AGES, AEMPS, SCC) at our facilities, and a high level of expertise in process optimization to stay ahead of ever-changing regulatory requirements.
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