SOPs for Analytical Method Development V 2.0

This SOP describes the procedure for preparing and reviewing analytical method validation reports to ensure that they are accurate, complete, and compliant with ICH Q2(R1), GMP, and internal quality standards. The report documents the results of the method validation study and forms the basis for regulatory submission and routine use.
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This SOP outlines the procedure for the preparation, review, and approval of validation protocols for analytical methods developed within the Analytical Method Development (AMD) department. It ensures that all validation studies are planned systematically and are compliant with ICH Q2(R1), WHO, and GMP requirements.
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This SOP outlines the process for developing discriminatory dissolution methods that can distinguish between formulation and manufacturing variables, ensuring method sensitivity, specificity, and regulatory compliance per ICH Q6A, WHO TRS 992, and FDA guidance.
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This SOP describes the process for developing robust and reproducible dissolution methods tailored for modified release formulations (e.g., sustained-release, extended-release, delayed-release) to assess drug release over an extended time period and meet regulatory expectations.
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This SOP outlines the methodology for developing and evaluating comparative dissolution profiles (CDPs) of test and reference formulations. It aims to support formulation equivalence and biowaiver submissions by demonstrating similarity using appropriate statistical tools and regulatory acceptance criteria.
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This SOP provides a standardized procedure for filtering and degassing dissolution media to remove particulate matter and dissolved gases that may interfere with dissolution testing results. Proper preparation of media is critical to ensure reproducibility and regulatory compliance during dissolution testing.
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This SOP outlines the procedure for selecting physiologically relevant pH values and evaluating the buffer capacity of dissolution media. Proper pH and buffering conditions ensure method robustness, consistent drug release, and compliance with ICH, WHO, and USP guidelines.
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This SOP outlines a standardized procedure to verify sink conditions for dissolution media used in analytical method development. Ensuring sink conditions supports method robustness and reproducibility, and complies with ICH, WHO, and USP regulatory standards.
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This SOP describes a standardized procedure for evaluating the de-aggregation behavior of tablets, capsules, and multiparticulate systems during dissolution testing. Proper de-aggregation is essential for accurate drug release and in vitro performance prediction.
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This SOP provides a systematic approach for evaluating dissolution apparatus suitability and optimizing rotational speed (RPM) to achieve reliable and reproducible dissolution profiles in the Analytical Method Development (AMD) department.
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