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Latest GMP News

FDA Warning Letter: Incoming Analysis of Raw Materials – Performing only an Appearance Test is not enough

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated March 10, 2020, to DermaPharm A/S, a Danish ...

Corona: UK expands QP Discretion

Annex 16 of the EU-GMP Guidelines (which is still valid in the UK) states that a “QP may consider confirming compliance ...

What does “State of Control” mean for the FDA?

In the context of process validation, the FDA attaches considerable importance to a “state of control“. The FDA ...

FDA Warning Letter: No Compendial Methods established? Develop appropriate Testing Procedures by yourself!

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Global Treat Srl. The firm manufactures ...

Version 17 of the Q&As on Safety Features for Track & Trace

Version 17 of the European Commission’s “Questions & Answers” (Q&As) on safety features has been ...

Remote Release and Remote Audits: New Answers from the EU

The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a ...

FDA Warning Letter to EU Company

All EU Member States are now part of the MRA (Mutual Recognition Agreement) between the EU and the FDA. The FDA was already ...

Evidenced Cross-Contamination at Indian Manufacturer results in Warning Letter

The FDA has recently issued a Warning Letter to a large Indian pharmaceutical manufacturer following an inspection that ...

FDA Warning Letter: Violations of GMP Fundamentals in Quality Control and Manufacturing Process

On March 13, 2020, the Chinese contract manufacturer for OTC products, Hangzhou Linkeweier Daily Chemicals Co. Ltd. received ...

New EU/EMA planned Actions in the Context of the COVID-19 Pandemic

The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the ...

Fraud in the Supply Chain: Beware of false Offers during Corona Crises

During the current Sars-CoV-2 outbreak, there are sometimes delivery problems with medicines, medical devices and protective ...

Update on COC / COP and Extractable Elements in Plastic Materials

Three drafts for new Ph. Eur. chapters on plastic materials have been published for comment in the recent issue of ...

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