Process validation: achieving the Operational Qualification phase.
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.
Buffaloe
Vera
V
Buffaloe Consulting, Inc., USA. verabuff@pipeline.com
D001698:Biomedical Engineering / Q000295:instrumentation* / Q000592:standards; D002138:Calibration / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D008283:Maintenance / Q000592:standards; D008422:Materials Testing / Q000379:methods / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration