MHRA: GMP Inspection Deficiencies 2013

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MHRA: GMP Inspection Deficiencies 2013

Сообщение News » 13 ноя 2014 17:18

MHRA: GMP Inspection Deficiencies 2013

MHRA just published inspection trend data from 2013. The report has been presented in a revised format, following comments from a stakeholder focus group. In addition to 2013 inspection deficiency data, the report also includes longer term trends in ‘top 10 deficiencies’ and highlights areas for continued focus.
The most frequently encountered defect categories raised over the previous five years have remained relatively consistent with the exception of ‘contamination, chemical/physical (or potential for)’ which has significantly increased.
Deficiencies relating to ‘quality systems’ are by far the most prevalent observed during inspections.
Over the last five years, where inspections identified major or critical deficiencies:
the ratio of Majors raised per inspection has remained relatively constant
the ratio of Criticals raised per inspection had remained relatively constant until 2013 where there was an increase observed. This is due to a cluster of data integrity issues with potential impact to public health.
the relative number of Critical deficiencies raised per inspection in a given continent is higher in Asia than other the other continents where inspections were carried out.
A number of areas for focus by the inspectorate have been identified based on review of the attached data, changes in the regulatory environment and due to intelligence gained from other agencies.
Fore more details, please have a closer look at the complete deficiency data review.

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