GMP News - Aseptic / Microbiology

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.

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.

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

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.

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.

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.

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.