EMA: More GMP/GDP Inspections performed

Recommendation

7/8 February 2023
Heidelberg, Germany

Combination Products
Medicinal Products/Drugs meet Medical Devices

According to the 2017 Annual Report of the European Medicines Agency EMA, which was recently published, the number of GMP and GDP inspections performed by EEA authorities increased again.

Last year, 2.493 sites were inspected worldwide for GMP. Out of these, 17 sites failed and received GMP non-compliance statements. In 2016, 2.293 GMP inspections were performed leading to 25 non-compliance statements.

These GMP Non-Compliance Statements can lead to a:

• a supply stop
• removal of a manufacturing site from the dossier
• removal/ replacement of a manufacturing site during the assessment procedure (prior approval)
• withdraw of an application for marketing authorisation
• recall of medicinal products

Most of the third country inspections were performed in India. Although the MRA with the USA was already on its way, the United States are on second place:

Figure: Inspection outcomes following EEA inspections performed in third countries in 2017 (with data extracted from EudraGMDP on 9th January). Source: EMA Annual Report

Also a high number of GDP inspections was performed in 2017; EEA authorities issued 1.928 GDP certificates and 6 GDP non-compliance reports.

*ROW includes the following countries: Argentina, Bangladesh, Brazil, Canada, Chile, Egypt, Iran, Japan, Jordan, Republic of Korea, Lebanon, The former Yugoslav Republic of Macedonia, Malaysia, Mexico, Monaco, Montenegro, Morocco, Oman, Pakistan, Russia, San Marino, Serbia, Singapore, South Africa, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam.

EMA's report also gives an overview on updates to the various Mutual recognition agreements (MRAs), other international co-operation and harmonisation activities and GMP and GDP Guidance.

Source: EMA Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2017.