QUALITY ASSURANCE - Used Laboratory Equipment and New Lab Instrument Supplies, UK

QUALITY ASSURANCE

Our client's Quality Assurance Unit (QAU) was established when the company was formed and accepted into the Good Laboratory Practice compliance Programme in 1989. Since then our client has undergone six Inspections from the Monitoring Unit under five different GLPMA inspectors. Sponsor Quality Assurance personnel have also inspected our client at regular intervals.

The QAU is independent of the Scientific Sections and is responsible for monitoring the planning, conduct and reporting of the studies and projects directed by our client's staff for compliance with Good Laboratory Practice regulations.

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

Section Capabilities

All Study/Phase Plans and Final Reports are subject to audit and these are signed for compliance with Good Laboratory Practice.
To ensure compliance with the UK guidelines for Good Laboratory Practice, the QAU at our client's carries out study-based, process-based and facility-based inspections within all Sections 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

The Expertise:

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