GMP News - Aseptic / Microbiology

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.

more

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.

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.

more

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.

more

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.

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.

more

14.08.12

FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing

In June, the FDA has published a new Question and Answer Guidance for Endotoxin and Pyrogen Testing. It should reflect the current thinking of the agency on that topic. Read more here.

more

14.08.12

New Homepage of ECA's Rapid Microbiological Methods Working Group

The new Rapid Microbiological Working Group website is now online - providing additional information about RMM. More details can be found here.

more

14.08.12

ECA's Rapid Microbiological Methods Conference

The annual Rapid Microbiological Methods Conference of the ECA will take place on 11. and 12 December in Munich, Germany. Many speakers from authorities, industry and method development already confirmed their participation. Get the details.

more

14.08.12

Case Study of New Growth-based Rapid Microbiological Method (RMM) detects the Presence of Specific Organisms

In the March Edition of the American Pharmaceutical Review, Dr Michael Miller published a case study of a New Growth-based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and provides an Estimation of Viable Cell Count. Read more.

more

11.07.12

FDA issues Amendment to the Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products

The FDA has published a Draft Guidance for Industry: Amendment to “Guidance for Industry: "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”. More details can be found here.

more

04.07.12

USP Chapter <62> Frequently Asked Questions

Recently, the USP published frequently asked questions relative to different General Chapters, amongst others to Chapter <62> Microbial Enumeration of Nonsterile Products: Tests for Specified Microorganisms. More details can be found here.

more

27.06.12

FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus

Scientists at the U.S. Food and Drug Administration (FDA) have confirmed that plasma specimens are well-suited for detecting the genetic material of hepatitis C virus (HCV) in potential blood donors who are infected with the virus. Read more.

more

15.02.12

Overview of FDA Warning Letters regarding the Manufacture of Sterile Medicinal Products

During fiscal year 2011, the US FDA issued a number of Warning Letters. Among them, many concerned the manufacture of sterile medicinal products. Read more here about the main deviations.

more

12.01.12

EMA, CVMP - Testing of Mycoplasma Contamination

CVMP published the draft guideline "VICH GL34: Biologicals: testing for the detection of mycoplasma contamination". It is is intended to facilitate the harmonized licensing of new products for veterinary use. More details can be found here.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics