GMP News - Aseptic / Microbiology

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.

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.

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.

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.

06.11.12

RMM database updated with new systems

The Rapid Microbiological Methods database in the member area of our working group was updated with 4 new systems, e.g. for sterility testing and Endotoxin detection. More details can be found here.

19.09.12

EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations

The European Medicines Agency has today agreed on a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis. Read more.

14.08.12

Dr. Claudius Micha Nübling becomes Member of the RMM Group Advisory Board

Dr Claudius Micha Nübling from the Paul-Ehrlich-Institut became member of the RMM Group Advisory Board. He will follow our longstanding Member Dr Thomas Montag. Read more here.

14.08.12

New Additions to the Literature List on ECA's RMM Website

The ECA Rapid Microbiological Methods working Group added new reports and articles to the literature list on its website . More can be found here.

14.08.12

Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research

The FDA's CBER published their strategic plan for regulatory science and research 2012 -2016. A possible further step for implementation of modern microbiological methods? Read more.

14.08.12

More Flexibility in Sterility Testing of biologic Products – FDA Amendments

Within FDA's scope - to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science, the US authority published amendments to the sterility testing rule. Read more about the background and contents.

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GMP News - Aseptic / Microbiology

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

Revision of USP 1223 - current Status

Rapid Micro Biosystems announces Availability of Growth Direct System

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

RMM database updated with new systems

EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations

Dr. Claudius Micha Nübling becomes Member of the RMM Group Advisory Board

New Additions to the Literature List on ECA's RMM Website

Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research

More Flexibility in Sterility Testing of biologic Products – FDA Amendments

Recommended Event

Data Integrity and Good Documentation Practice GMP-compliant instructions and records

GMP News - Aseptic / Microbiology

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

Revision of USP 1223 - current Status

Rapid Micro Biosystems announces Availability of Growth Direct System

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

RMM database updated with new systems

EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations

Dr. Claudius Micha Nübling becomes Member of the RMM Group Advisory Board

New Additions to the Literature List on ECA's RMM Website

Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research

More Flexibility in Sterility Testing of biologic Products – FDA Amendments

Recommended Event

Data Integrity and Good Documentation Practice GMP-compliant instructions and records

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