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Elements· Identifying Target Product Quality Profile TPQP. · Identifying CQA’s. · Design product and defining product layout space. · Process layout and defining manner layout space. · Defining handle method. · Process validation. · Regulatory filings. · Process tracking, life cycle control and continuous benefit. Quality by Design ToolsTarget product profileTPP. 14, 15The role of objective product profile TPP is case study serve as case solution tool for “excellent planning” for case evaluation drug product with “the tip in mind” i. e. a summary of case evaluation drug advancement program described in case evaluation context of prescribing information goals. A high-quality objective product profile QTPP is case solution term that is case solution herbal extension of TPP for product high-quality . 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