EMA Update on On-site GMP and GDP Inspections Approach for 2024 - Celegence

EMA Update on On-site GMP and GDP Inspections Approach for 2024

The latest news on the approach in 2024 by the GMP/GDP Inspectors Working Group is that the validity of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) certificates has been extended until 2024 or until the completion of the next on-site inspection, whichever comes first, unless otherwise stated in the document.

This extension is due to the considerable number of postponed inspections that still need to be carried out following the COVID-19 public health emergency. The GMP/GDP Inspectors Working Group is expected to issue guidelines on the approach for 2024 in the coming months.

This document will likely address the following topics:

  • Specific arrangements for remote working of Qualified Persons
  • A clear plan for completing all postponed inspections
  • Guidance on how to manage the transition to full compliance with GMP and GDP regulations

In the meantime, manufacturers should continue to comply with all applicable GMP and GDP regulations. They should also be prepared to cooperate with inspectors when their inspections are scheduled.

Here are some additional resources that you may find helpful:

Phasing out of extraordinary COVID-19 regulatory flexibilities: https://www.ema.europa.eu/en/news/phasing-out-extraordinary-covid-19-regulatory-flexibilities
European Medicines Agency (EMA): https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice
GMP/GDP Inspectors Working Group: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/gmp-gdp-inspectors-working-group
European GDP Association (EGPA): COVID-19 and Good Distribution Practice (GDP): https://www.good-distribution-practice-group.org/home.html

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