GMP News - Aseptic / Microbiology

26.08.15

French Authority (ANSM) published statement of non-compliance related to mould contaminations

TxCell has shut down their pilot site in Besançon due to some deviations found during an inspection of the French authority. Amongst others, several mould contaminations were found. Read more details about the report of the authority.

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04.08.15

European Pharmacopoeia - Chapter 2.6.27 Microbiological Examination of cell-based Preparations revised

The issue 27.3 of Pharmeuropa also comprises a revision of Chapter 2.6.27 "Microbial Examination of cell-based Preparations". It covers the cases where a test is not feasible according to chapter 2.6.1.

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06.05.15

Contamination Control - Still an issue during inspections

Measures for contamination control are one of the basic requirements for the manufacturing of medicinal products. Still, contamination control issues got back in the TOP TEN List of 21 CFR 211 Citations. Read more about contamination control as an issue during inspections.

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29.04.15

ECA Foundation and its Interest Group European QP Association comment on EU GMP Annex 1 Revision

In February 2015 the European Commission published a Concept Paper with the intent to revise the EU GMP Annex 1 on sterile manufacturing. The time frame provided by the EU Commission is very small.  End of March 2015 has been set as deadline for industry comments and in October 2015 a draft version of the revised EU GMP Annex 1 is planned to be published. Read more about the industry comments on the revision of Annex 1 to the EU GMP Guide.

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06.11.14

Ph.Eur Chapter 2.6.8. Pyrogens Revision open for Comments

In Pharmeuropa issue 26.4, the EDQM published the draft of the revision of chapter 2.6.8. Pyrogens. It is open for comments until 31. December 2014. Read more.

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06.11.14

Question and Answers to Endotoxin Masking and Low Endotoxin Recovery (LER)

Following ECA's webinar on Endotoxin Masking, the speaker summarized the questions related to masking and LER in a Q&A document. Read more here.

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06.11.14

EDQM revises 5.1.10. Guidelines for using the Test for Bacterial Endotoxins

Recently, the EDQM published the revision of 5.1.10. "Guidelines for Using the Test for Bacterial Endotoxins" and added alternative methods like recombinant factorC. More details can be found here.

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08.10.14

New FDA Interim Guidance for Human Drug Compounding Outsourcing Facilities

Compounding pharmacies in the US haven't been inspected by the FDA over the past years. For the first time, after a number of serious incidents which caused death, the FDA has tried to establish cGMP requirements for the manufacturers of outsourced drug compounding in an interim guidance for Industry. Read more details here.

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02.09.14

RMM Working Group announces Changes on its Board

Due to changes in their careers, to professional re-orientation or due to retirement, four of the RMM board members will step out from their RMM activities and leave the board of the group. Read more about the new members here.

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02.09.14

Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

FDA published a draft Guideline on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. It is a result of FDAs activities to reduce the outbreaks of Toxic Anterior Segment Syndrome (TASS). Read more here.

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02.09.14

Draft USP Chapter 1223 Validation of Alternative Microbiological Methods published

The USP published the draft of the revised chapter 1223 "Validation of Alternative Microbiologiocal Methods." Read more.

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02.09.14

RMM Homepage - Update and new Structure of Literature List

During the first months of 2014, the literature part of the RMM homepage was re-structured. More about the new structure of the subpages with the regulatory background, literature reports and articles about the different types of Rapid Microbiological Methods can be found here.

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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.

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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.

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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.

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