GMP News - Aseptic / Microbiology

02.09.14

RMM Working Group announces Changes on its Board

Due to changes in their careers, to professional re-orientation or due to retirement, four of the RMM board members will step out from their RMM activities and leave the board of the group. Read more about the new members here.

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02.09.14

Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

FDA published a draft Guideline on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. It is a result of FDAs activities to reduce the outbreaks of Toxic Anterior Segment Syndrome (TASS). Read more here.

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02.09.14

Draft USP Chapter 1223 Validation of Alternative Microbiological Methods published

The USP published the draft of the revised chapter 1223 "Validation of Alternative Microbiologiocal Methods." Read more.

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02.09.14

RMM Homepage - Update and new Structure of Literature List

During the first months of 2014, the literature part of the RMM homepage was re-structured. More about the new structure of the subpages with the regulatory background, literature reports and articles about the different types of Rapid Microbiological Methods can be found here.

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15.11.13

New system added - Rapid Microbiological Methods Database updated

The Rapid Microbiological Methods database in the member area of our working group was once again updated with new systems. Find out more.

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15.11.13

FDA publishes ICH Q4B Annex 14 for Interchangeable Endotoxin Testing between ICH Regions

The US FDA adopted the "ICH Guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests - general chapter". Read more.

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15.11.13

PDA TR33 Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

The Parenteral Drug Association published the revised Technical Report No. 33 on Alternative and Rapid Microbiological Methods. Read more here.

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16.10.13

USP Draft of a newly proposed Chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products

In the Pharmacopoeial Forum 39(4), USP published the draft of the long time expected chapter on Bioburden Control of Nonsterile Drug Substances and Products. Read more here.

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15.10.13

Rapid Microbio Methods Database updated with new systems

The Rapid Microbiological Methods database in the member area of our working group was updated with 3 new systems. For more information please see this news.

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15.10.13

EMA publishes ICH Q4B Annex 14 - Bacterial Endotoxin Tests

The European Medicines Agency (EMA) published ICH guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests". Read more.

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15.10.13

Use of Nucleic Acid Tests

With this guidance, the FDA addresses blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture. Read on.

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11.07.13

FDA - Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

Related to the HCT/Pdonor testing, the FDA/CBER has updated their page with licensed donor screening tests and further information about safety for relevant communicable disease agents and diseases. Read more.

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19.06.13

Answers by EMA on the Topic Bioburden

The questions "For an aseptically produced product, where should bioburden monitoring take place?" and "What is the maximum accepted bioburden level?" are answered by EMA on its questions and answers page. Read more.

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29.05.13

Gaseous Sterilization - New USP General Chapter <1229.7>

The new USP General Chapter <1229.7>, "Gaseous Sterilization" will provide an overview of gaseous sterilization and its validation. The use of sterilizing gases for the preparation of materials and equipment is in widespread application for items that are susceptible to damage by heat or radiation processes. You will find more information in this news.

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15.05.13

Dry Heat Sterilization - New USP General Chapter <1229.8>

The new USP General Chapter <1229.8>, "Dry Heat Sterilization" will provide an overview of dry heat sterilization and its validation. You will find more information in this news and in the Pharmacopeial Forum.

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