Quality Assurance Service

The CEMAS Quality Assurance Unit (QAU) was established when the company was formed and accepted into the Good Laboratory Practice compliance Programme in 1989. Since then, CEMAS has undergone nine Inspections from the Monitoring Authority. Sponsor Quality Assurance personnel have also inspected CEMAS QAU at regular intervals.

The QAU is independent of the Scientific Sections and is responsible for monitoring the planning, conduct, reporting and archiving of the studies and projects directed by CEMAS staff for compliance with Good Laboratory Practice (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practice (GMP) regulations.

These monitoring activities are conducted in accordance with individual QAU Standard Operating Procedures and current guidelines (GLP, GCP and GMP) and are reported to Study Directors, Principal Investigators, Section Managers and Company Management as appropriate.

Section Capabilities

• All Study/Phase Plans and Final/Phase of Interim Reports are subject to audit and these are signed for compliance with Good Laboratory Practice.
• To ensure compliance with the UK guidelines for GLP, the QAU at CEMAS carries out study-based, process-based and facility-based inspections within all Sections of the facility.
• To ensure compliance with the EU guidelines for GCP and GMP, the QAU at CEMAS carries out study-based, process-based and facility based inspections within the Pharmaceutical Section of the facility.

Multi-Site Studies:

The QAU also undertakes audits of procedures and documentation in Multi-Site Studies including:

• Residue Trials
• Soil Dissipation
• Feeding Studies
• Operator Exposure
• Cooling Tower Half-Life
• Multi-Site Pharmaceutical Studies

The Expertise:

• Members of the QAU staff have a lengthy and broad experience of audits in many other regulatory areas including Toxicology (General and Cellular)  and a wide range of laboratory and manufacturing experience prior to joining QAU.
• The QAU staff are all members of the British Association of Research Quality Assurance and we can offer advice on GLP, GCP and GMP issues and conduct audits where required on a consultancy basis.