Preparing for and handling agency inspections for the United Kingdom Department of Health.

This paper indicates some known differences in approach adopted by the United Kingdom Department of Health (DoH) Good Laboratory Practice (GLP) Monitoring Authority from that of other agencies and offers guidance to quality assurance (QA) professionals in dealing effectively with a DoH inspection. The UK GLP Programme contains, at present, just over 100 member laboratories, ranging from one-man pathology outfits to major companies with perhaps over 1000 staff working in compliance. Laboratories in the GLP program are subject to routine inspection every 2 years; without a satisfactory inspection and continued membership in the GLP program, UK laboratories cannot make a formal claim of compliance. Routine inspections occur at 2-year intervals, with a formal period of notice, allowing some preparation to occur. Routine inspections comprise the selection of a small number of studies for audit and inspection of all the facilities. Inspectors look critically at QA and management systems and routinely interview staff to get a feel for the skills, knowledge, competence, and attitude of those who work on nonclinical studies. Study directors are constant targets for the inspectors' inquisition. Throughout the inspection process, inspectors are accompanied by senior QA staff, whose notes are used to ensure that nothing in the final meeting is reported incorrectly or out of context. The inspectors leave after verbal discussion with management of any significant findings. A full written report is typically provided within 3 weeks, to which a written response from management is required within 4 weeks. There is no Freedom of Information program in the UK.