QA/QC

Oct 02, 2017
Pharmaceutical Technology
Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry.
Oct 02, 2017
Pharmaceutical Technology
This article discusses fully automatic inspection of glass and plastic containers and factors that affect particle detection rate. 
Sep 08, 2017
Six years after the guidance, it’s time to change our quality assurance vocabulary.
Sep 02, 2017
Pharmaceutical Technology
When it comes to getting the best out of quality by design, timing is everything.
Sep 02, 2017
Pharmaceutical Technology
Forced degradation studies can identify stability problems for drug substance and drug products.
Aug 16, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
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.
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