Auch die Anvisa hat sich dem internationalen Trend angeschlossen und mit der neuen 7. Version der brasilianischen Pharmakopoea den MAT als alternativen Pyrogentest aufgenommen.
The USP continues to work on updating its chapters around endotoxin testing and is publishing a proposed revision to Chapter <1085> Guidelines on Endotoxin Test.
In a Warning Letter to a manufacturer of non-sterile drugs in the USA, the FDA summarises a whole series of deficiencies. Serious deficiencies were found both in microbiological control and deviation handling as well as in analytics.
The USP follows suit! Following other pharmacopoeias, the USP is now also publishing a chapter <86> on recombinant reagents for testing for endotoxins, thereby following the worldwide endeavour to reduce the use of animal materials.
Disinfectants play an important role in contamination control. It is not always easy to recognise which agents or active substances have which advantages and disadvantages. You can find a brief overview of the different groups of active substances in this short, clear summary.
At the beginning of August, the FDA issued a Warning Letter to a US company that had shown deficiencies in the areas of product and process control through to stability analysis during an inspection. The Warning Letter was a result of the company's inadequate response after receiving a 483 form following an FDA inspection.
At the beginning of July, the FDA published a Warning Letter due to a lack of chemical and microbiological controls in the manufacture of a product for dermal application and inadequate testing of the ingredients used.
A new version (Rev. 62) of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was created in May 2024 and published on the HMA (Heads of Medicines Agencies) website. The new version of the Q&A catalogue now includes question 3.32. and its answer.
The FDA issued a Warning Letter to a compounding facility with microbiological safety deficiencies. Deficiencies were found in deviation handling and test validation.
