GMP News - Aseptic / Microbiology


Urgent Revision of EP 5.2.8. Minimising the Risk of Transmission of animal Spongiform Encephalopathy

With date of application on 1st july, the chapter 5.2.8 of the EP about Minimising the Risk of transmission of Animal Spongiform Encephalopathy agents via human or veterinary medicinal products was revised. More details can be found here.



ECDC - Technical Report on the Prevention of Creutzfeldt–Jakob (vCJD) published

In June the ECDC (European Centre for Disease Prevention and Control) published a technical report on the prevention of Creutzfeldt-Jakob (vCJD) disease transmission in medical settings in EU Member States and Norway. Read more.



WHO Technical Report including Annex 2 "Good Practices for pharmaceutical microbiological Laboratories"

The WHO Expert Committee published  their Technical Report on specifications for pharmaceutical preparations. In its Annex 2 his report includes the "WHO good practices for pharmaceutical microbiology laboratories". More details can be found here.



FDA proposes Changes in Sterility Testing of Biological Products

In the latest edition of the Federal Register, FDA announced proposed changes in the requirements on sterility testing of biological products. Get the details here.



In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens

On 23 May the US Health and Human Services Department published a notice in the Federal Register which includes nomination of In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens; Data Request for Substances Evaluated by these Test Methods. More details can be found here.



EP 2.6.31. Microbiological Examination of herbal medicinal Products for oral Use under Revision

The EDQM announced the revision of the monograph 2.6.31. "Microbiological examination of herbal medicinal products for oral use" which specifies inspections for herbal drugs with particular specifications for Escherichia coli, salmonella and gram-negative bacteria with bile salt tolerance. More details can be found here.



Note for Guidance on minimising the Risk of transmitting Animal Spongiform Encephalopathy Agents via human and veterinary Medicinal Products

Regarding the developments in research and sciences of TSE and the current data about BSE arround the world, the European Commission revised the "Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products". Read more here.



Guideline on Testing for the Detection of Mycoplasma Contamination of veterinary medicinal Products

The CVMP of the European Medicines Agency published the draft of VICH GL34: Guideline on testing for the detection of mycoplasma contamination for further consultation. More about the guideline can be found here.



USP <85>Bacterial Endotoxin Test - proposed interim Revision Announcement

The USP proposed an interim revision of chapter <85> "Bacterial Endotoxin Test" based on a recommendation of the FDA and additions to the harmonised texts. Find out more here.



USP <1113> Microbial Identification - In Process Revision including a title change

The United States Pharmacopeia revises chapter <1113> about microbial characterisation, identification and strain typing including a change of chapters name. Read more here.



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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