Quality Systems

Oct 23, 2017
By Pharmaceutical Technology Editors
The company is recalling several injectable products because of possible microbial contamination.
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. 
Oct 02, 2017
Pharmaceutical Technology
Is there a difference between a specification and a standard?
Oct 02, 2017
Pharmaceutical Technology
Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Sep 28, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
Sep 28, 2017
By Pharmaceutical Technology Editors
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
Sep 25, 2017
Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.
Sep 15, 2017
Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.
Sep 14, 2017
By Pharmaceutical Technology Editors
The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.
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