QA/QC

May 16, 2017
Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.
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.
Apr 27, 2017
By Pharmaceutical Technology Editors
Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.
Apr 02, 2017
Pharmaceutical Technology
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Mar 02, 2017
Pharmaceutical Technology
Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.
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?
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