Compliance Tips for Biotechnology Companies
Tips on FDA Inspections and the Most Common Reasons Pharmaceutical/Biotech Companies are Issued a Form FDA-483
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:
- Most common reasons why pharmaceutical companies receive a Form FDA-483
- Things that investigators look for in terms of training and training control
- What investigators look for when evaluating a CAPA system
- What companies should do to prepare for a GMP inspection
- What companies should do when they receive a Form FDA-483
- Top three areas that FDA investigators are trained to focus on during GMP inspections.
About MasterControl Biotechnology Compliance Tips
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.
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