GMP NEWS 2021

Brexit Agreement - what now?

Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products?

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ICH Q9 Risk Management to be Revised

Since 2005, the ICH Guideline Q9 has been the state of the art when it comes to quality risk management (QRM) in the GMP environment. Now it is to be revised. What is planned?

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New MHRA Inspectorate Blog GDP Post: Be aware of Fake Websites when Qualifying New Customers and Suppliers Using Online Resources

Qualification and re-qualification of suppliers and customers are a fundamental part of Good Distribution Practice (GDP). Using online resources and publicly available databases is established as a standard requirement during this process. But relying (only) on information that is easily available to everyone may involve a high risk. In this context, a new post, entitled “Qualifications of suppliers and customers online: reliable or fake news?” has been published in the MHRA Inspectorate blog.

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New Approach for Dissolution or Disintegration Tests in Ph. Eur. Monographs to be Published in Supplement 10.6.

A new policy for dissolution and disintegration testing in European Pharmacopoeia (Ph. Eur.) monographs has been adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form.

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FDA Warning Letter: No Adequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

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