GMP News - Aseptic / Microbiology

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.

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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.

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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.

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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.

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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.

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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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10.08.11

Urgent Revision of EP 5.2.8. Minimising the Risk of Transmission of animal Spongiform Encephalopathy

With date of application on 1st july, the chapter 5.2.8 of the EP about Minimising the Risk of transmission of Animal Spongiform Encephalopathy agents via human or veterinary medicinal products was revised. More details can be found here.

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10.08.11

ECDC - Technical Report on the Prevention of Creutzfeldt–Jakob (vCJD) published

In June the ECDC (European Centre for Disease Prevention and Control) published a technical report on the prevention of Creutzfeldt-Jakob (vCJD) disease transmission in medical settings in EU Member States and Norway. Read more.

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08.08.11

WHO Technical Report including Annex 2 "Good Practices for pharmaceutical microbiological Laboratories"

The WHO Expert Committee published  their Technical Report on specifications for pharmaceutical preparations. In its Annex 2 his report includes the "WHO good practices for pharmaceutical microbiology laboratories". More details can be found here.

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08.08.11

FDA proposes Changes in Sterility Testing of Biological Products

In the latest edition of the Federal Register, FDA announced proposed changes in the requirements on sterility testing of biological products. Get the details here.

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01.06.11

In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens

On 23 May the US Health and Human Services Department published a notice in the Federal Register which includes nomination of In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens; Data Request for Substances Evaluated by these Test Methods. More details can be found here.

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11.05.11

EP 2.6.31. Microbiological Examination of herbal medicinal Products for oral Use under Revision

The EDQM announced the revision of the monograph 2.6.31. "Microbiological examination of herbal medicinal products for oral use" which specifies inspections for herbal drugs with particular specifications for Escherichia coli, salmonella and gram-negative bacteria with bile salt tolerance. More details can be found here.

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20.04.11

Note for Guidance on minimising the Risk of transmitting Animal Spongiform Encephalopathy Agents via human and veterinary Medicinal Products

Regarding the developments in research and sciences of TSE and the current data about BSE arround the world, the European Commission revised the "Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products". Read more here.

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24.02.11

Guideline on Testing for the Detection of Mycoplasma Contamination of veterinary medicinal Products

The CVMP of the European Medicines Agency published the draft of VICH GL34: Guideline on testing for the detection of mycoplasma contamination for further consultation. More about the guideline can be found here.

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22.02.11

USP <85>Bacterial Endotoxin Test - proposed interim Revision Announcement

The USP proposed an interim revision of chapter <85> "Bacterial Endotoxin Test" based on a recommendation of the FDA and additions to the harmonised texts. Find out more here.

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