Compendial Compliance

Sep 07, 2018
Pharmaceutical Technology
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
Jul 19, 2018
By Pharmaceutical Technology Editors
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Jul 02, 2018
By Pharmaceutical Technology 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 Pharmaceutical Technology 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 Pharmaceutical Technology Editors
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
Apr 06, 2018
By Pharmaceutical Technology Editors
The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.
Mar 13, 2018
By Pharmaceutical Technology Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Feb 02, 2018
Pharmaceutical Technology
Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.
Feb 02, 2018
Pharmaceutical Technology
Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.
Dec 12, 2017
The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
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