News

Just recently, you could read about the Good Manufacturing and Distribution Practice Symposia 2023, organized by the Medicines and Healthcare products Regulatory Agency (MHRA) on 21 and 22 February 2023. A summary of the GDP part was now published on the MHRA Inspectorate blog.

More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 2 here.

After the public access to the GDP Non-Compliance Reports in EudraGMDP did not function for several weeks, reports can now be accessed again. In the meantime, four new documents have been added by the competent authority of Czechia. In all cases, the companies did not provide approved storage facilities.

The U.S. Food and Drug Administration (FDA) has published a new guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act". The document clarifies the agency's interpretation of specific terms used in the definitions of "suspect product" and "illegitimate product". It is primarily intended to assist trading partners in meeting verification obligations.