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GMP News

EMA publishes new Q&A Document on Remote RP Activities

The European Medicines Agency (EMA) has published a new Q&A document on Remote RP activities. Remote activities by the Responsible Person may be permitted, but should occur within the EU/EEA or Northern Ireland in all cases.

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Questions and Answers from the ECA Webinar "GDP Update 2024" - Part 2

Almost 100 participants attended the ECA Webinar "GDP Update 2024" in March. Many interesting aspects were discussed in the Q&A session. The speaker, Dr. Christian Grote-Westrick, has answered the questions 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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Checklist for Implementation of GDP Principles - Part 7: Outsourced Activities

According to Chapter 7 of the EU GDP Guidelines, any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. In this article, you will find a checklist to verify the minimum implementation.

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