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Open Access Austin Journal of Analytical and
Pharmaceutical Chemistry
Research ArticleDevelopment and Validation of HPLC Method for
Simultaneous Estimation of Montelukast and Loratadine
in Pharmaceutical
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What is development and validation of?
Development and validation refer to the processes that ensure a product, service, or system meets its intended purpose and performs consistently within specified limits.
Who is required to file development and validation of?
Organizations and individuals involved in the creation and testing of products, particularly in regulated industries such as pharmaceuticals and biotechnology, are required to file development and validation.
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Filling out development and validation typically involves completing specific forms that detail the processes undertaken, results obtained, and compliance with relevant standards; supporting documentation should also be included.
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The purpose of development and validation is to demonstrate that a product is effective, safe, reliable, and fulfills its intended use, thereby ensuring compliance with regulatory requirements.
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Information that must be reported includes the objectives of the development, methodologies used, results and findings, variations noted, and conclusions drawn regarding efficacy and safety.
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