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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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ECA publishes Contamination Control Strategy Guideline

In order to support its members, but also to support the industry in general in implementing the requirement of the upcoming revised Annex 1 for a Contamination Control Strategy, the ECA has published a CCS Guideline. This document provides guidance and a template for the development of a contamination control strategy.

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New FDA Draft Guidance - Microbiological Quality Control of Non-Sterile Medicinal Products

Based on the experience of the past years, the FDA has published a new draft guidance that deals with the microbiological control of non-sterile medicinal products and clarifies it by means of case studies.

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New FDA Q&As on Endotoxin Testing

As part of its Q&A series, the FDA has published a draft guidance on various quality topics, including questions on endotoxin testing.

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FDA Warning Letter due to contaminated Hand Disinfectants

As a result of problems with contamination of hand disinfectants - like with Burkholderia cepacia, a manufacturer in the USA receives a Warning Letter from the FDA.

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FDA: Warnings about Side Effects and Contamination with Hand Disinfectants

The FDA is warning against certain hand sanitizers because of side effects and contamination, especially during the COVID-19 pandemic. The latest notifications concern alcohol-based hand sanitizers.

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The End for the Rabbit Test - only Alternative Methods in 5 Years

Following its 170th meeting the Commission of the European Pharmacopoeia announced that after a defined transition period the pyrogen rabbit test will be completely replaced.

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