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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:208969Orig1s000 PRODUCT QUALITY REVIEW(S)Table of ContentsExecutive Summary.....2 Drug Substance....6 Drug Product.23 Environmental........50
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What is quality overall summary?
Quality overall summary is a document that provides an overview of the quality of products or services.
Who is required to file quality overall summary?
The companies or organizations that provide products or services are required to file quality overall summary.
How to fill out quality overall summary?
Quality overall summary can be filled out by providing details about the quality control processes, tests, and results.
What is the purpose of quality overall summary?
The purpose of quality overall summary is to assess and demonstrate the quality of products or services.
What information must be reported on quality overall summary?
Information on quality control measures, testing procedures, and overall quality assessment must be reported on quality overall summary.
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