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GMP News

FDA Warning Letter to a Manufacturer of an Athlete Muscle Maintenance Creme

At the beginning of July, the FDA published a Warning Letter due to a lack of chemical and microbiological controls in the manufacture of a product for dermal application and inadequate testing of the ingredients used.

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EDQM publishes updated Ph.Eur. Water Monographs for comment

The EDQM has revised the monographs Water for Injection (0169), Purified Water (0008) and TOC Level in Pharmaceutical Water (2.2.44) and has now published them for comment. Learn more about the EDQM water monographs.

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FDA describes detailed CAPA Procedure in Warning Letter

The FDA rarely goes into great detail about expected measures in its Warning Letters, especially not when it comes to instructions on the desired procedure. This is now different in a Warning Letter that was published in July. It describes in considerable detail what the FDA considers to be appropriate CAPA measures in a specific case.

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