GMP News - Aseptic / Microbiology

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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10.04.13

Harmonisation of Bacterial Endotoxin Testing - ICH guideline Q4B Annex 14

In May 2013, the new ICH Q4B Annex 14 for bacterial endotoxin tests in the ICH regions will become effective. More details can be found here.

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19.12.12

New Method to Directly Sequence Small Genomes Without Library Preparation

For the first time, researchers sequenced DNA molecules without the need for the standard pre-sequencing workflow known as library preparation. Read more here.

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21.11.12

FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit)

On November 1st, 2012, the MycoTOOL® PCR Mycoplasma Detection Kit-based test from Roche Applied Science was approved by the U.S. Food and Drug Administration (FDA) for release testing of a  Roche biopharmaceutical product. More details here.

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21.11.12

New guideline for DNA Sequences could prevent erroneous Data

A international team of researchers, with it’s core at the University of Gothenburg, Sweden, has prepared a guide to assist the scientific community in the quality control process. Find out more.

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21.11.12

Revision of USP 1223 - current Status

The Vice-Chair of the USP General Chapters – Microbiology Expert Committee, Tony Cundell, recently provided an update to the chapter’s revision process and what we should see when the draft is published in a future issue of the Pharmacopeial Forum. Read more.

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20.11.12

Rapid Micro Biosystems announces Availability of Growth Direct System

New applications should improve the efficiency of microbial quality control processes while significantly reducing the time-to-result. More details can be found here.

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06.11.12

EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines

The EMA/CHMP published an assessment report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines. More details can be found here.

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