Quality Assurance/Quality Control

Jul 02, 2017
Pharmaceutical Technology
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Jun 26, 2017
By Pharmaceutical Technology Editors
Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.
Jun 14, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
Jun 02, 2017
Pharmaceutical Technology
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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.
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