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Warning Letter to US Company due to Lack of Product and Process Control

At the beginning of August, the FDA issued a Warning Letter to a US company that had shown deficiencies in the areas of product and process control through to stability analysis during an inspection. The Warning Letter was a result of the company's inadequate response after receiving a 483 form following an FDA inspection.

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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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CMDh/HMA: New Update of the Q&A List on Variations

A new version (Rev. 62) of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was created in May 2024 and published on the HMA (Heads of Medicines Agencies) website. The new version of the Q&A catalogue now includes question 3.32. and its answer.

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Handling of Microbiological Deviations and Sterility Testing - FDA publishes Warning Letter

The FDA issued a Warning Letter to a compounding facility with microbiological safety deficiencies. Deficiencies were found in deviation handling and test validation.

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CTIS: EMA´s Risk Mitigation Plan

A risk mitigation plan is available to help CTIS users carry out regular activities within the system in different risk scenarios. In case of system failure and persistent system downtime, submissions of clinical trials data, assessment and supervision of authorized trials outside CTIS should be allowed.

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Transmission of Malaria by Blood Donors - FDA updates Guidance Document

As a result of the specifics of the pandemic situation over the past two years, the FDA is issuing an update to its recommendations for reducing malaria transmission during transfusions. It replaces the April 2020 guidance.

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FDA Information on bacterial Contamination of Platelets for Transfusion

After 2019 and 2021, the FDA will again update its findings and recommendations regarding bacterial contamination of platelet preparations for transfusion purposes.

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Pyrogenicity Testing - European Pharmacopoeia continues to be updated

The European Directorate for the Quality of Medicines published a new chapter 5.1.13. PYROGENICITY, dealing with testing for pyrogens, for comment.

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Ethanol - an important Active Ingredient for Infection Prevention?

WHO, KRINKO and RKI are concerned with the pending biocide approval and indispensability of ethanol as a component of infection prevention and healthcare. They have published a corresponding statement.

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Revision of Chapter 2.6.7 of the European Pharmacopoeia published for Comment

After about 10 years, the EDQM has now published a draft revision of Chapter 2.6.7 on mycoplasma testing, which will be available for comment until the end of June.

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