The EMA has published three further statements on nitrosamine. Find out what marketing authorisation holders of drugs with chemically synthesised APIs ought to do regarding potential nitrosamine contamination.
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.
The just published Version 16 of the Q&As on Safety Features puts a strong focus on Q&As addressing false alerts due to incorrect scanning by end-users.
A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa.
MHRA gives further guidance for a new Responsible Person function, the RPi - Responsible Person (import).
FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy".
A set of new FAQs has been published on Chapter 4 (Documentation) and Chapter 5 (Operations).
The MHRA recently provided details for new licence applications and variations on the agencys Inspectorate Blog - together with some helpful links.
In June 2018, when it became known that the antihypertensive medicinal product Valsartan contained nitrosamines, no one had any idea how widespread these unwanted side-products were. Read more here to find out what action the EMA and EDQM have taken in the past and in response to the latest cases of nitrosamine contamination.
For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.