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The assessment should determine: Whether the water becomes a product ingredient Whether the product is parenteral or nonparenteral Whether the process is sterile, aseptic, or nonsterile Whether the water contacts product-contact equipment Whether it is used for an initial wash or final rinse Whether it contacts containers or closures Whether endotoxin control is required Whether microorganisms or objectionable organisms create product risk Whether the water is removed during later processing Whether a subsequent validated process step controls the identified risk Whether a product monograph, formulation, analytical method, approved filing, or label specifies a water category Whether the water will be administered directly to a patient Whether the water is generated onsite, delivered in bulk, or purchased as a packaged article Water-category selection should follow the principles described in the Risk-Based Approach to Validation, with emphasis on product exposure, process stage, downstream controls, and patient risk
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