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.
The European Commission and the EDQM have published a new chapter of the European Pharmacopoeia for testing bacterial endotoxins with recombinant factor C (rFC) for public comment.
The revised Annex 1 to the EU-GMPs will bring a lot of new requirements. One of the major developments is the need for the implementation of a comprehensive Quality Risk Management System.
