GMP News - Aseptic / Microbiology


FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections

An FDA investigation associated with a multistate outbreak has identified the bacteria Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured. More details at the FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections.



Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 3

Once again, the American FDA has addressed a Warning Letter to an Indian Manufacturer of sterile medicinal products. Major and serious violations of GMP principles were identified at the Indian Manufacturer Emcure Pharmaceuticals Limited. Part 3 of this news will deal with the issue of insufficient documentation. You will find more information on the most important deficiencies in this Warning Letter here.



EDQM announces revision of general chapter Monocyte Activation Test (2.6.30)

On 23 June, the EDQM in Strasbourg announced the revision of the pharmacopoeial general chapter 2.6.30 on Monocyte Activation Test.



EDQM Survey on new General Chapter on microbiological Control of Tissue

The European Directorate for the Quality of Medicines & Healthcare (EDQM) published a survey to gather information from relevant stakeholders for elaboration of a chapter on microbiological control of tissues.



New Orientation for ECA Foundation RMM Working Group

The ECA Foundation's Rapid Microbiological Methods (RMM) Working Group was originally established in June 2006 at the Paul-Ehrlich-Institut (PEI) - the German Federal Agency for Vaccines and Biomedicines. Now the Foundation announced a new orientation for its RMM Working Group.



Revision of BAM Chapter 23: Microbiological Methods for Cosmetics

In May 2016, the FDA published some revisions in the text of the Bacteriological Analytical Manual, Chapter 23, "Microbiological Methods for Cosmetics".



Italian Manufacturer receives FDA Warning Letter for Hygiene Issues

On 20 May 2016, the U.S. American FDA published a Warning Letter for major hygiene issues in aseptic manufacturing. Find out more about the Warning Letter issued for the Italian manufacturer Corden Pharma Latina S.p.A.



New Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 1

Again, the US American FDA has issued a Warning Letter to a manufacturer of sterile medicinal products. Comprehensive and serious violations of GMP principles were observed at the Indian manufacturer Emcure Pharmaceuticals Limited. Part 1 of the News deals with the topic insufficient aseptic practices. Read more about the most significant deviations in the Warning Letter.



Non-Compliance Reports for European Manufacturers of Sterile Medicinal Products

The Spanish and the Polish competent authorities have currently published two Non-Compliance Reports because of major deviations in the manufacturing of sterile medicinal products. Read more details about the new Non-Compliance reports.



Pharmeuropa - Comments concerning revised texts about Bacterial Endotoxins

In December the EDQM published the comments concerning revised texts of chapter 5.1.10. Guidelines for using the Test for Bacterial Endotoxins. Find out more about the scope and the added specific points in the Test for Bacterial Endotoxins Guideline.



FDA Guidance finalised: Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

On 17 August, the FDA published the finalised Guidance for Industry and Food and Drug Administration Staff  "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices".



Revised Draft of Pharmeuropa Monograph 5.1.2. Biological Indicators

End of 2011 the Pharmeuropa 24.1 published a first draft of the monograph "5.1.2. Biological Indicators in the Preparation of Sterile Products" for discussion. Due to the abundance of comments, the draft was substantially revised and is now available in the Pharmeuropa 27.3 for comments again. Read more about the current Draft 5.1.2. Biological Indicators.



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.



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.



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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