Medicines: good manufacturing practice and good distribution practice

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) provides this guidance for all UK-based pharmaceutical manufacturers and wholesale dealers regarding Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) inspections. The regulatory framework is governed by the EU rules for medicinal products, EU GDP guidelines, and the MHRA’s Orange and Green Guides. Inspections are conducted periodically based on a company's risk rating, though they may also be triggered by whistleblowers or other regulatory authorities. The agency identifies three types of deficiencies: Critical (significant risk of patient harm or counterfeit medicine infiltration), Major (deviations from marketing licenses or failed batch releases), and Other (minor departures from standards). Upon completion of an inspection, companies are required to submit a formal email response outlining specific corrective and preventative action (CAPA) plans and expected completion timelines. If deficiencies are not resolved, the MHRA may initiate a compliance escalation process or refer the case to the Inspection Action Group, which has the authority to suspend or refuse licenses. Since January 1, 2021, the MHRA continues to recognize GMP inspection outcomes from EEA authorities under mutual recognition agreements.