The FDA regulates the pharmaceutical industry according to a host of regulations, including the Current Good Manufacturing Practice (CGMP) outlined in 21 CFR Parts 210 and 211.
Validation of manufacturing processes, handling of deviations, and laboratory operations are the top three areas that FDA investigators scrutinize during GMP inspections, according to a senior regulatory operations officer with the Center for Drug Evaluation and Research (CDER).
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In this question-and-answer article, MasterControl Inc. interviewed a CDER official who discussed:
The MasterControl integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance. MasterControl connects different departments with each other and with data and processes under a secure and centralized Web-based system. This connectivity helps promote quality throughout the enterprise by allowing management to continuously monitor and proactively improve the quality processes. MasterControl helps pharmaceutical companies meet key CGMP requirements and ISO quality standards, and at the same time increase efficiency and keep compliance costs down.
Contact MasterControl representative for more details about pharmaceutical compliance tips.