title: Process validation: achieving the Operational Qualification phase.
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.
authors.affiliation: Buffaloe Consulting, Inc., USA. verabuff@pipeline.com
authors.forename: Vera
authors.initials: V
authors.lastname: Buffaloe
mesh_terms: 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