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.
Our European Unit holds a Manufacturing Authorisation for Investigational Medicinal Products, MIA (IMP) and, in-line with the requirements of the GMP regulations, the Quality Assurance Unit is responsible for:
- Checking assembly/manufacturing documentation
- Review and approval of Change Controls
- Approval of Deviations & Annual Review
- Review of Environmental Monitoring Results
Our Quality Assurance Units advise on training requirements in Good Practice regulations and guidelines. The Company Archive is maintained by our dedicated archivist under the control of the Quality Assurance Manager.
Our Quality Assurance Units have extensive experience in hosting Sponsor Audits and Regulatory Inspections in relation to preparation, facilitation and follow-up.
