Process validation: achieving the Operational Qualification phase.

Vera Buffaloe

doi:10.2345/0899-8205(2004)38[384:pvatoq]2.0.co;2

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Process validation: achieving the Operational Qualification phase.

Vera Buffaloe

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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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Biomedical Engineering Calibration Equipment and Supplies Guidelines as Topic Humans Maintenance Materials Testing Quality Control Reproducibility of Results United States United States Food and Drug Administration Journal Article

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Vera Buffaloe. Process validation: achieving the Operational Qualification phase.. https://doi.org/10.2345/0899-8205(2004)38%5B384%3Apvatoq%5D2.0.co%3B2

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