Quality

Jul 02, 2017
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Russell Madsen, president, The Williamsburg Group, and member of the Pharmaceutical Technology editorial advisory board, shares his thoughts on technology innovations and regulatory implications.
Jul 02, 2017
Pharmaceutical Technology
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Jul 02, 2017
Pharmaceutical Technology
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
Jul 02, 2017
Pharmaceutical Technology
The more pharma science and technology change, the more business and policy concerns stay the same.
Jul 02, 2017
Pharmaceutical Technology
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jun 27, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Raritan Pharmaceuticals, Inc. after an inspection found quality testing and misbranding violations.
Jun 19, 2017
By Pharmaceutical Technology Editors
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
Jun 16, 2017
By Pharmaceutical Technology Editors
The company recalled a variety of products due to the potential of microbial contamination.
Jun 16, 2017
By Pharmaceutical Technology Editors
The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.
Jun 09, 2017
By Pharmaceutical Technology Editors
In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.
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