Quality Assurance
Algorithme Pharma and Simbec are quality driven companies committed to the provision of accurate, rapid and reliable results. Our dedicated Quality Assurance Units provide an audit programme which covers the requirements of the regulatory authorities in relation to the good practices that apply to the highly regulated pharmaceutical industry. Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice quality systems are applied to all aspects of our 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, GCP and GMP, and Clinical Pathology Accreditation 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, AFSSAPS, MHRA, AGES) at our facilities.
The QA Unit has a high level of expertise in process optimisation and quality systems and one of its key aims is 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
- Our supplier qualifications programme
- Management of SOPs (including their revision, and distribution)
- Coordination of all client audits
- Management of data archival
Our European Unit holds a Manufacturing Authorisation for Investigational Medicinal Products, MIA (IMP).
