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Sterility Testing, GPT and More - Warning Letter of the US FDA with various deficiencies

In July, the FDA published a warning letter to Exela Pharma Sciences, which, in addition to deficiencies in microbiological tests and inspections such as sterility tests, growth promotion tests and environmental monitoring, also included a whole series of other deficiencies. It was the consequence of an inadequate response to the FDA's previous 483 letter.

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Microbiological Updates of the Pharmacopoeias

Various pharmacopoeias are currently revising chapters relevant to microbiology. This affects various areas, from rapid methods to potency determination for phage therapies, which is located in many microbiology departments.

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Pharmaceutical Microbiology Group Developments January through April 2025

Find out what the ECA Pharmaceutical Microbiology Group was working on and accomplished in the first four months of 2025 - in the latest report.

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Microbiology - EDQM asks for Comments on the new or revised Chapters

Chapters with microbiological relevance are currently being published or revised in a whole series of pharmacopoeias. Chapters on rapid methods, pyrogenicity and endotoxin testing are also currently published for comment in the European Pharmacopoeia.

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Become a speaker at PharmaLab 2025 - Analytics, Bioanalytics, Microbiology and more

The 13th PharmaLab Congress from November 24-28, 2025 will take place as usual in Neuss/Düsseldorf with two pre-conference workshops and several parallel conferences. As always, it offers you the opportunity to become part of the speaker team and submit a presentation to share your knowledge with colleagues and discuss the respective experiences. So, become part of the team of speakers - and submit your proposal for a presentation via our online form.

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14 Submissions for the Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology 2025

The Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology will once again be presented at the PharmaCongress on 8 and 9 April in Wiesbaden. This year, 14 projects have applied for the award, with topics ranging from optimised technology to AI applications.

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USP publishes Draft Chapter on Contamination Control Strategy

With the draft chapter <1110>, the USP completes its programme with recommendations on the subject of contamination control strategy, as already called for in other documents.

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From Burkholderia to Ethylene Glycol - a List of Deficiencies at a Manufacturer of OTC Products

A manufacturer of OTC products from Mesquite, Texas received a Warning Letter from the US FDA for deficiencies in various areas ranging from microbiology and raw material analysis to cleaning and disinfection.

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Inadequate Microbiological Testing of Nonsterile Products - FDA Warning Letter

In a Warning Letter to a manufacturer of non-sterile drugs, the FDA criticized, among other deficiencies, a lack of testing of the manufactured batches for microbiological quality in accordance with USP chapters <61> and <62>, which deal with the "Enumeration" test and the test for "Specified Microorganisms".

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EMA Q&A - When is Testing for Endotoxin Masking Effects necessary for biological Products?

The EMA has recently published an update to its question and answer catalog for biological medicinal products. Among other things, it also addresses the question of when endotoxin masking effects must be taken into account for biological products.

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