Quality Assurance/Quality Control

Nov 15, 2017
By Pharmaceutical Technology Editors
The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.
Nov 13, 2017
Investing in a single source enterprise-wide LMS to fuel risk management and mitigation offers multi-dimensional return on investment.
Nov 09, 2017
By Pharmaceutical Technology Editors
FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.
Nov 02, 2017
Pharmaceutical Technology
In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.
Nov 02, 2017
Pharmaceutical Technology
Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.
Nov 02, 2017
Pharmaceutical Technology
The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.
Nov 02, 2017
Pharmaceutical Technology
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
Oct 11, 2017
By Pharmaceutical Technology Editors
FDA published guidance on the format and content of REMS documents.
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. 
native1_300x100
lorem ipsum