SOPs for Analytical Method Development V 2.0

To define the process for preparation, review, approval, implementation, and periodic revision of the Analytical Method Development (AMD) Master Plan. This SOP ensures harmonized planning aligned with GMP, ICH Q8-Q11, and WHO guidelines to support product development and regulatory submissions.
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To outline a systematic approach for conducting risk assessments during analytical method development (AMD) to ensure method robustness, reliability, and regulatory compliance as per ICH Q9, ICH Q8, and GMP guidelines.
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To establish a controlled procedure for the identification, review, and implementation of pharmacopoeial monographs in the Analytical Method Development (AMD) laboratory in accordance with regulatory guidelines and current good manufacturing practices (cGMP).
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This SOP provides guidance for conducting comprehensive literature reviews to support analytical method development in compliance with regulatory standards such as ICH, WHO, and GMP. The literature review ensures that the method is scientifically sound, appropriately justified, and supported by existing knowledge.
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This SOP provides guidance for selecting appropriate analytical techniques for method development in pharmaceutical analysis. The selection process is aligned with ICH Q2(R1), Q8, and WHO guidelines to ensure method suitability, regulatory compliance, and scientific soundness.
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This SOP defines the systematic process for developing test procedures for active pharmaceutical ingredients (API), ensuring that all analytical methods are scientifically justified, robust, and aligned with ICH Q2(R1), GMP, and regulatory expectations.
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To establish a standardized procedure for the development of analytical test procedures for pharmaceutical formulations including tablets, capsules, oral liquids, injectables, and topical products. This ensures accuracy, precision, and regulatory compliance across product types.
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To define the systematic approach for selecting suitable mobile phases for chromatographic techniques such as HPLC, UPLC, and GC, ensuring reliable analyte separation, method robustness, and compliance with ICH Q2(R1) and GMP expectations.
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This SOP describes the procedure for evaluating the feasibility of analytical methods prior to method development or optimization, focusing on the assessment of technical suitability, practical execution, and expected performance in compliance with ICH Q2(R1) and GMP guidelines.
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To define a systematic approach for optimizing analytical methods developed for the quantitative and qualitative analysis of pharmaceutical substances and products. This includes evaluating critical method parameters to ensure accuracy, precision, robustness, and regulatory compliance as per ICH Q2(R1).
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