Abstract
The OQ phase of process validation is very important and is where the complete understanding of the process is determined by experimentation. This understanding is useful to: * establish optimal process parameters * understand variation that affect the process * aid in investigating process deviations. OQ is an important part of the entire process validation activity and essential to understanding a manufacturing process. The benefits of completing the OQ and overall process validation are the reasons that it makes business sense and receive the long-term benefits of producing high quality product and achieving customer satisfaction.
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