Quantcast
Channel: New Drug Approvals
Viewing all articles
Browse latest Browse all 2871

The “Industry Coalition” gives practical advice for the control of elemental impurities in active substances and excipients

$
0
0

Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:

The requirements of the “Guideline for Elemental Impurities ICH Q3D” published in December of last year mean a considerable expense for the affected pharmaceutical companies and drug manufacturers in terms of laboratory and personnel upgrading (see also our news about “ICH Q3D – Elemental Impurities” of 07 January 2015). In addition, the deadlines for the implementation of this guideline are quite tight. (June 2016 for newly approved drugs and December 2017 for already approved drugs, see our news “CHMP adopts ICH Q3D Guideline as “Scientific Guideline” of 21 January 2015).

In the March issue of “Pharmaceutical Technology Europe”, an article of the “Industry Coalition” has been published with the title “Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities“, which is intended to support the efffected companies with a number of pragmatic pieces of advice in the implementation of these requirements.

View original 275 more words


Filed under: Uncategorized

Viewing all articles
Browse latest Browse all 2871

Trending Articles



<script src="https://jsc.adskeeper.com/r/s/rssing.com.1596347.js" async> </script>