February 14, 2006 — /MasterControl/ — 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).
In this question-and-answer article, MasterControl Inc. interviews a CDER official to talk about:
–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.
MasterControl Inc. has been at the forefront of providing innovative quality management software solutions since 1993. Over 400 companies worldwide use the MasterControl(tm) solution to consistently meet FDA regulations, ISO standards, and other regulatory requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. For more information or additional white papers, visit www.mastercontrol.com or call 800-825-9117.