Compendial Compliance

Jul 19, 2018
By BioPharm International Editors
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Jul 02, 2018
By BioPharm International Editors
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
May 17, 2018
By BioPharm International Editors
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
Apr 30, 2018
By BioPharm International Editors
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
Apr 06, 2018
By BioPharm International Editors
The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.
Apr 01, 2018
BioPharm International
Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Aug 24, 2017
By BioPharm International Editors
The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.
Aug 01, 2017
BioPharm International
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Jun 01, 2017
BioPharm International
An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.
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