Quality

Feb 02, 2016
Pharmaceutical Technology
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.
Feb 01, 2016
Pharmaceutical Technology
Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.
Feb 01, 2016
By Pharmaceutical Technology Editors
CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.
Jan 27, 2016
By Pharmaceutical Technology Editors
Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.
Jan 20, 2016
By Pharmaceutical Technology Editors
Abbott’s Compounding Pharmacy voluntarily recalls sterile products due to lack of sterility assurance.
Jan 06, 2016
By Pharmaceutical Technology Editors
The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.
Jan 06, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.
Jan 05, 2016
By Pharmaceutical Technology Editors
Baxter voluntarily recalls two lots of intravenous solutions due to particulates.
Jan 02, 2016
Pharmaceutical Technology
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
Dec 10, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.
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