SOPs for Analytical Method Development V 2.0

The purpose of this SOP is to establish clear guidelines for documenting scientific work, including observations, calculations, and results in laboratory notebooks within the Analytical Method Development (AMD) department. This ensures data integrity, traceability, and compliance with current regulatory standards such as ALCOA+ and Good Laboratory Practices (GLP).
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The purpose of this SOP is to define the standardized procedure for the proper handling, documentation, review, and archiving of raw analytical data generated during method development activities. It ensures traceability, transparency, and data integrity in compliance with ALCOA+ principles, GMP, and regulatory standards.
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To lay down a procedure for the qualification, labeling, documentation, usage, and storage of pharmacopoeial reference standards (RS) and secondary working standards (WS) used in the Analytical Method Development (AMD) department.
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This SOP defines the procedure for recording analytical calculations and completing raw data worksheets to ensure data accuracy, traceability, and compliance with Good Documentation Practices (GDP) during Analytical Method Development (AMD).
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This SOP defines the structured process for the development of stability indicating analytical methods capable of distinguishing the active pharmaceutical ingredient (API) from its degradation products. These methods are essential to ensure drug safety, efficacy, and regulatory compliance over shelf-life.
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