Thursday, 20 April 2023 10.00 - 16.30 h
The U.S. Food and Drug Administration FDA has been communicating GMP non-compliance issues in their Form 483 or in Warning Letters. Under the Freedom of Information Act, those documents have been accessible to the public for a long time. So far, EU inspectorates did not publish any results of their inspections. This is changing now.
The European Medicines Agency (EMA) has launched a new version of the EudraGMDP database which includes, among other changes, the publication of statements of non-compliance with Good Manufacturing Practices (GMPs).
Regulatory authorities conduct inspections of manufacturing sites and issue GMP certificates when they conclude that a site is GMP compliant. When inspectors conclude that a site is not GMP compliant, a statement of non-compliance with GMP is issued and regulatory authorities enter the document in EudraGMDP. These non-compliance documents are now publicly accessible as well as the positive GMP certificates.
Statements of non-compliance contain information on the nature of the non-compliance and the actions taken or proposed by the issuing authority in order to protect public health. These statements aim to establish a coordinated and harmonised response by the network of European Union (EU) medicines regulators.
Most information contained in EudraGMDP is publicly available. Information of a commercially or personally confidential nature is not made public. The decision on which information to make public is taken by the medicines regulatory authority in the EU Member State that adds the information to the database.
The current Non-Compliance Reports can be found here.
Source: EMA Press Release
By the way, FDA Form 483s are available under the Electronic Freedom of Information Act Amendments of 1996, but may be redacted to remove non-public information. The FDA publishes selected 483s on their website: ORA FOIA Electronic Reading Room.
Warning Letters are made available here. Published letters are redacted or edited to remove confidential information.