Good manufacturing practice and good distribution practice:an analysis of regulatory inspection findings for 2001-02

摘要

An analysis is presented of the serious deficiencies reported on inspections by the United Kingdom Medicines Control Agency of pharmaceutical manufacturers and distributors in the UK and countries outside the European Union or European Economic Area during 2001-2002.The primary purpose of this article is to provide an indication to manufacturers of the most common failures to comply the EU guidance on Good Manufacturing Practice and Good Distriubtion -ractice and Good Distribution Practice,as recorded by MCA GMP and GDP inspectors.The findings and the sues to which they may be put are discussed.