GMP News - Aseptic / Microbiology

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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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QC Compliance Manager - Live Online Training

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GMP News - Aseptic / Microbiology

New system added - Rapid Microbiological Methods Database updated

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

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

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

Rapid Microbio Methods Database updated with new systems

EMA publishes ICH Q4B Annex 14 - Bacterial Endotoxin Tests

Use of Nucleic Acid Tests

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

Answers by EMA on the Topic Bioburden

Gaseous Sterilization - New USP General Chapter <1229.7>

Dry Heat Sterilization - New USP General Chapter <1229.8>

Harmonisation of Bacterial Endotoxin Testing - ICH guideline Q4B Annex 14

New Method to Directly Sequence Small Genomes Without Library Preparation

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

New guideline for DNA Sequences could prevent erroneous Data

Recommended Event

QC Compliance Manager - Live Online Training

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