The Monitoring of GMP Compliance in the Development of Medicinal Products in the United Kingdom

Abstract

There is currently no European Community (EC) directive which requires the inspection and authorization of the manufacture of medicinal products for use in clinical trials. The United Kingdom Medicines Inspectorate, however, carries out voluntary inspections, on request, on a fee-charging basis, and reports on good manufacturing practice (GMP) compliance. The standards applied reflect those described in Annex 13 of the EC “Guide to GMP” and the inspection process closely follows that for a licensed manufacturer. Standards of GMP found in United Kingdom manufacturers of investigational products so far are generally acceptable. but some particular noncornpliances are noted regularly. Of concern in a small number of cases is the lack of assurance of the control of cross-contamination. The United Kingdom wouldsupport. in principle, an EC move toward the licensing of the manufacture of clinical trials supplies, but it would be concerned to ensure that any regulation was sympathetic to the nature and scale of the operation.