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Abbreviations in the GDP Environment

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. We have prepared such an overview.

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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 3

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 3 here.

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Annual Report and updated Work Plan of the GMDP Inspectors Working Group - What's going on in GDP?

The European Medicines Agency (EMA) has published the annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2022. An updated work plan 2021-2023 has also been issued.

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Summary of the MHRA Good Distribution Practice Symposium 2023

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.

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GDP Non-Compliance Report: No authorized Storage Facilities and Services of a Qualified Person not ensured

After the competent authority of Czechia (State Institute for Drug Control) had just recently added four GDP Non-Compliance Reports to the EudraGMDP database, another one was added at the end of April 2023.

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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 2

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.

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GDP in the US: USP Chapter and Stimuli Article on MKT

In the Pharmacopeial Forum, PF 49(2), a proposal for a revised USP General Chapter <1079.2> "Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products" and a Stimuli Article "The Use of Mean Kinetic Temperature and the Need of Allowable Excursion Limits for Climatic Zone IVb" were published. Comments can be submitted until 31 May 2023.

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Competent Authority of Czechia issues four new GDP Non-Compliance Reports

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.

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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 1

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 1 here.

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GDP in the US: New FDA Guidance for Industry on Definitions of Suspect Product and Illegitimate Product

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.

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