At BioAnaLab we recognise the importance of performing studies not only to the highest standards of scientific integrity but also in compliance with regulatory requirements. To achieve this we have a quality system that complies with current good pharmaceutical practices (GxPs) and an independent Quality Assurance department (reporting directly to the CEO) with many years combined experience working in a regulated environment. QA representatives are assigned to each client for the lifetime of a client project. This ensures studies are performed to UK regulations for GMP, GLP or GCP, as appropriate and where compliance is required. All BioAnaLab studies adhere to the principles of the relevant GxPs.

The Quality Assurance team operates a programme of study based audits and audits of the facility and quality system and regularly host audits from clients, potential clients and from regulatory agencies.

Quality Assurance is responsible for:

• Regular internal auditing of client studies and BioAnaLab facilities
• Training in quality system and regulations
• Tracking/trending of deviations
• Administering the corrective / preventive action system
• Administering the document change control system
• Review of computerized system validations
• Review of equipment qualification, calibration and maintenance
• Supplier approval and performance monitoring
• Monitoring and reporting of quality system performance metrics to management

Quality Standards

BioAnaLab operates one Quality System which has been designed to satisfy the requirements of Good Laboratory Practice (GLP), Good Clinical Practice, (GCP), Good Manufacturing Practice (GMP) and Good Clinical Laboratory Practice (GCLP). All studies are performed to this same high standard, whether they are intended for research and development or for submission to a regulatory authority. For regulatory studies, the study is performed to the relevant GxP and a claim of compliance to the GxP is made in the final study report.

The quality system and our practices have been inspected by the UK MHRA. As a result we are:

• Full members of the UK GLP Monitoring Authority Scheme, since January 2006
• Members of MHRA GCP Laboratory Inspection Scheme, since March 2008
• A contract analysis site for biological testing under the MHRA Voluntary QC Laboratory GMP Scheme, since January 2008

We have also been inspected and certified by Qualogy Ltd to the voluntary Good Clinical Laboratory Practice (GCLP) scheme run by Qualogy Ltd since Sep 2005. This is a voluntary scheme for clinical laboratories conducted against the GCLP guidelines published by the British Association of Research Quality Assurance (BARQA).

For more information on the quality system, please request a copy of our Site Master File.