GMP and GDP: a review of regulatory inspection findings and defective medicines reports for 2004

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The Pharmaceutical Journal
Vol 276 No 7401 p593-596
20 May 2006

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GMP and GDP: a review of regulatory inspection findings and defective medicines reports for 2004–05

The purpose of this article is to indicate to manufacturers and distributors areas on which they may wish to focus their training programmes, internal audit and quality improvement, in order to increase their compliance with Good Manufacturing Practice and Good Distribution Practice

John Taylor, FRSC, is the quality and standards manager of the MHRA’s inspection and standards division and enforcement and intelligence group

Gerald Heddell, MIBiol, is director of the inspection and standards division

Ian Holloway, MRPharmS, is the head of the Defective Medicines Report Centre

Graham Matthews, MRPharmS, is a pharmaceutical assessor in the DMRC

Ian Rees, MRCVS, is a senior GMP inspector

Correspondence to:
John Taylor
Medicines and Healthcare Products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

SUMMARY

This article reports the nature and frequency of serious deficiencies in compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) found on regulatory inspections by the Medicines and Healthcare products Regulatory Agency (MHRA) during the year 2004–05. It covers industrial manufacturing and distribution sites in the UK, manufacturing sites in third countries and sites where the NHS is the licence holder. Data for the years 1996–97, 1998–99 and 2001–02 were published previously. The paper also reviews reports of defective medicines received by the MHRA’s Defective Medicines Report Centre (DMRC) and drug alerts issued in 2005 to support recalls issued by the relevant importers, manufacturers and marketing authorisation holders.

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