GMP News - Aseptic / Microbiology

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.

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.

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.