Culture of Pharmaceutical Quality: Improving Quality Management System
Posted on December 15, 2015
By: Ajaz S. Hussain, Ph.D.
Insight Advice and Solutions LLC. Frederick, MD 21702, USA*, and The National Institute for Pharmaceutical Technology & Education
Introduction Regulatory observations of breaches in the assurance of data integrity are among the most serious allegations of CGMP violations. When such observations are followed by a Warning Letter and/or Import Alert it indicates that regulators have lost trust in company’s quality management sy...
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Related Topics and Keywords
Ajaz S. Hussain, breaches assurance data, CGMP violations, CPQ, Culture of Pharmaceutical Quality, Global Quality Management System, National Institute of Pharmaceutical Technology and Education, QMS, quality management system, Regulatory observations
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