GMP News - Aseptic / Microbiology

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.

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.

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.

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.

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The FDA has published a Draft Guidance for Industry: Amendment to “Guidance for Industry: "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and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.

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.

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.

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.

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.

02.11.11

FDA Inspectional Observations on Hygiene, Cleaning and Sanitation

The overview about FDA deficiency reports (Form 483) still shows a large number of objections with regard to hygiene, cleaning and disinfection. Concerned are the classic medicinal products manufacture as well as the areas biologicals and medical devices. Read more.

20.10.11

FDA Q&As on pathogenic Contamination of animal-derived Drug Ingredients

The Food and Drug Administration (FDA) published some new Q&A on contamination of animal based drug ingredients. Read more here.

13.10.11

Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005-2010 Revision Cycle

Scott Suttion and Radhakrishna Tirumalai issued a review of the published activities of the Microbiology and Sterility Assurance Expert Committee (MSA EC) of the United States Pharmacopeial Convention (USP) Council of Experts for the 2005–2010 revision cycle. Read more here.

09.09.11

Faster Sterility Tests for Biological Products

The FDA published a scientific poster on "Identifying faster Sterility tests for Biological Products - Regulatory Research Seeks to Reduce the Time Needed to Ensure the Safety of Critical Products". Read more.

09.09.11

Rapid Methods - Influence of FDA's Strategic Plan for advancing Regulatory Science

In August, the FDA published a Strategic "Plan to Advancing Regulatory Science at FDA". This plan includes statements to amend microbial safety of products with modern microbiological methods. Read more.

17.08.11

EMA Position Statement on Creutzfeldt-Jakob Disease and advanced Therapy medicinal Products

In June 2011, the CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products was agreed to by the Biologics Working Party and adopted by the CHMP/CAT. Read more here.

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GMP News - Aseptic / Microbiology

FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing

New Homepage of ECA's Rapid Microbiological Methods Working Group

ECA's Rapid Microbiological Methods Conference

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

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

USP Chapter <62> Frequently Asked Questions

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

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

EMA, CVMP - Testing of Mycoplasma Contamination

FDA Inspectional Observations on Hygiene, Cleaning and Sanitation

FDA Q&As on pathogenic Contamination of animal-derived Drug Ingredients

Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005-2010 Revision Cycle

Faster Sterility Tests for Biological Products

Rapid Methods - Influence of FDA's Strategic Plan for advancing Regulatory Science

EMA Position Statement on Creutzfeldt-Jakob Disease and advanced Therapy medicinal Products

Recommended Event

ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis Part of the ICH Q7 Training Courses 2024

GMP News - Aseptic / Microbiology

FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing

New Homepage of ECA's Rapid Microbiological Methods Working Group

ECA's Rapid Microbiological Methods Conference

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

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

USP Chapter <62> Frequently Asked Questions

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

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

EMA, CVMP - Testing of Mycoplasma Contamination

FDA Inspectional Observations on Hygiene, Cleaning and Sanitation

FDA Q&As on pathogenic Contamination of animal-derived Drug Ingredients

Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005-2010 Revision Cycle

Faster Sterility Tests for Biological Products

Rapid Methods - Influence of FDA's Strategic Plan for advancing Regulatory Science

EMA Position Statement on Creutzfeldt-Jakob Disease and advanced Therapy medicinal Products

Recommended Event

ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis Part of the ICH Q7 Training Courses 2024

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