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Journal of Pharmaceutical and Biomedical Analysis 61 (2012) 271276 Contents lists available at Diverse ScienceDirect Journal of Pharmaceutical and Biomedical Analysis journal homepage: www.elsevier.com/locate/jpba
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What is development and validation of?
Development and validation refer to the process of designing and testing new products or procedures to ensure their effectiveness, safety, and compliance with regulatory standards.
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The requirement to file development and validation depends on the specific regulations and industry standards. Generally, it is the responsibility of the manufacturer or developer of the product or procedure.
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The purpose of development and validation is to ensure that new products or procedures meet the necessary requirements, perform as intended, and do not pose risks to the users or the environment.
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The information to be reported on development and validation may include but is not limited to the design specifications, test methods, testing results, risk assessments, and any necessary documentation to demonstrate compliance with regulatory standards.
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