Module 5 Presentations

Inspection Differences 2

MHRA

EMA-coordinated

FDA

Only key documents retained

Only key documents retained

Many document requests retained

Verbal feedback at closing (with provisional gradings)

Verbal feedback at closing (not always provisional gradings)

483 report must be given at close of inspection

One inspection report (includes all sites related to inspection)

Inspection report for each site plus an Integrated Inspection Report (IIR) summarising all sites

Various reports mainly for internal FDA circulation

CAPA required to ensure continued improvement

Corrective actions and assessment of impact on data submitted

No requirement for preventative actions

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Other MHRA Inspections

GMP: to confirm that IMP and medicine manufacturing processes are of a consistent high quality, medicines are appropriate for their intended use and meet the requirements of the marketing authorisation (MA) or product specification.

GLP: any test facility which conducts, or intends to conduct, regulatory studies and must belong to the UK compliance monitoring programme.

GPvP: monitoring the safety of medicines on sale to the public in the UK.

GDP: requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.

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