Debora Gallorini -

Since March 2020, MHRA Inspectorate has not conducted on-site inspections unless they were  linked to the UK Government’s COVID-19 response or any other potential serious public health risk.

Consequently, most of the GMP certificates released by MHRA were going to expire due to impossibility to organize inspections. For this reason, the validity of the certificates has been extended initially to 2021, then to the 2022 and, recently MHRA has announced that the expiry has been further extend until the end of 2023.

On November 8th, 2022, MHRA Inspectorate announced the resuming of the programme of international onsite GMP inspections. The decision has been taken following the successful results obtained during the pilot programme of International onsite GMP inspections started in April 2022.

After two years, UK and the world itself are gradually returning to the “normal” life and international travels are now becoming easier to be organized. In April 2022, MHRA launched a pilot program, involving GMP Inspectors, with the aim to evaluate a potential return to onsite international GMP inspections. The risk assessment that was conducted led to a favourable result for the resumption of inspections.

The inspections will be managed adopting a risk-based approach, precedence will go to the ones with the greatest impact on UK public health and patient safety. Sites will be contacted directly by the authority to arrange the inspections.

Regulatory Pharma Net (RPN) can provide support in preparation of GMP inspections by undertaking gap analysis prior to the inspection by the regulatory agency.



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