It has always been known that the processes involved in pharmaceutical production impact
significantly on the quality of the products The processes include raw material and
equipment inspections as well as in-process controls. Process controls are mandatory in
good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line
performance of the manufacturing process, and hence, validate it. Thus validation is an
integral part of quality assurance. This overview examines the need for pharmaceutical …

Overview of Pharmaceutical Validation and Process Controls in Drug Development -
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