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Typical applications include: Purified Water or a justified higher quality for nonsterile product-contact equipment WFI for final rinsing of parenteral product-contact equipment WFI where endotoxin control is required Another specified quality where supported by the product, process, approved filing, and validated cleaning procedure Final-rinse water quality does not, by itself, validate the cleaning process

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In accordance with § 425.600(g)(1)(i) through (iii), an ACO that is inexperienced with performance-based risk Medicare ACO initiatives may participate under the BASIC track's glide path for a maximum of two agreement periods: ++ An ACO that enters an agreement under the BASIC track's glide path at either Level A or Level B is deemed to have completed one agreement under the BASIC track's glide path and is only eligible to enter a second agreement under the BASIC track's glide path if the ACO continues to meet the definition of inexperienced with performance-based risk Medicare ACO initiatives and satisfies either of the following: (A) the ACO is the same legal entity as a current ( or previous ACO that previously entered into a participation agreement for participation in the BASIC track's glide path only one time