GMP News - Aseptic / Microbiology


Complete Revision of USP Chapter <1116> including updated Cleanroom Classification

In the USP Pharmacopeial Forum Volume 36, No. 6, the chapter <1116> "Microbial Evaluation of Clean Rooms and other Controlled Environmentsis" has been published with the status "In-process-revision". Read here more about the proposed changes.



Revision of EP chapter 5.1.6. Alternative Methods for Control of Microbiological Quality

European Pharmacopoiea: The Modern Microbiological Methods Working Party published a questionnaire to the revision of Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality Rapid Microbiological Methods. More details can be found here.



FDA Publishes Statement on the Frequency of Media Fills

In the document "Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs", the FDA publishes statements on topical subjects. Recently, the authority published a statement on the number of annual media fills in relation to the number of shifts and depending on the use of isolators. Find more here.


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