Two weeks after their microbiology symposium in Strasbourg, the European Directory for the Quality of Medicines and HealthCare (EDQM) summarized the event in their press release entitled "Microbiological control symposium: consensus on readiness of new methods emerges".
Reaching step 5 of the harmonisation process, the European Medicines Agency (EMA) adopted the ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration.
The International Council for Harmonistion (ICH) finalized their recommendation relating to the use of the pharmacopoeial texts on tests for specified microorganisms.
The FDA issued a Q&A document correlated to the final rule on Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.
The Japanese Pharnacopoe has published a new chapter draft of "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay" for comment.
Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.
The US FDA issued a Warning Letter to a US company with aseptic production due to serious deficiencies in room zoning, personnel, environment monitoring and disinfection.
