GMP News - Aseptic / Microbiology

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.

Compounding pharmacies in the US haven't been inspected by the FDA over the past years. For the first time, after a number of serious incidents which caused death, the FDA has tried to establish cGMP requirements for the manufacturers of outsourced drug compounding in an interim guidance for Industry. Read more details here.

FDA published a draft Guideline on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. It is a result of FDAs activities to reduce the outbreaks of Toxic Anterior Segment Syndrome (TASS). Read more here.

During the first months of 2014, the literature part of the RMM homepage was re-structured. More about the new structure of the subpages with the regulatory background, literature reports and articles about the different types of Rapid Microbiological Methods can be found here.

The US FDA adopted the "ICH Guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests - general chapter". Read more.

In the Pharmacopoeial Forum 39(4), USP published the draft of the long time expected chapter on Bioburden Control of Nonsterile Drug Substances and Products. Read more here.