QA/QC

Aug 16, 2017
By Pharmaceutical Technology Editors
Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.
Jul 12, 2017
By Pharmaceutical Technology Editors
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
Jul 02, 2017
Pharmaceutical Technology
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
May 15, 2017
Pharmaceutical Technology
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
May 02, 2017
Pharmaceutical Technology
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Feb 01, 2017
Pharmaceutical Technology
By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.
Feb 01, 2017
Pharmaceutical Technology
More life-sciences companies are starting to manage global suppliers holistically.
Jan 02, 2017
Pharmaceutical Technology
As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.
Nov 15, 2016
Pharmaceutical Technology
Could greater market transparency improve pharmaceutical quality and regulatory compliance?
Nov 02, 2016
Pharmaceutical Technology
Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.
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