EMA: Validity of GMP and GDP Certificates in 2024
On 7 December 2023, the European Medicines Agency (EMA) published an important update on the validity of GMP certificates after COVID-19 on its Good Manufacturing Practice website:
The validity of GMP and GDP certificates, which were automatically extended to the end of 2023 under COVID-19, will be extended until 2024. Either the validity date until 2024 or the conclusion of the next on-site inspection applies, whichever comes first unless stated otherwise in the relevant document. The working group of GMP/GDP inspectors decided to continue the extension.
There are still a considerable number of inspections outstanding that have had to be postponed due to the pandemic. The competent authorities will prioritise these based on risk. Manufacturers with the highest priority, e.g. manufacturers of sterile products and biological products, and wholesaler distributors will be inspected first. In addition, inspections will be prioritised according to the date of the last inspection.
Questions regarding the validity date of a GMP or GDP certificate should be addressed to the competent authority that issued the certificate. More information and further updates can be found here.
Source:
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
