SOPs for Analytical Method Development V 2.0

This SOP defines the procedure for qualification, documentation, storage, and usage of reference standards in the Analytical Method Development (AMD) department to ensure accuracy, traceability, and compliance with applicable regulatory requirements including ICH Q6A, WHO TRS, and pharmacopeial standards.
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This SOP describes the procedure for evaluating whether an analytical method is ready for validation. It ensures all prerequisite studies, documentation, and performance criteria are completed and acceptable before initiating full validation per ICH Q2(R2) and Q14 requirements.
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This SOP describes the procedure for preparation, qualification, labeling, storage, and use of working standards in the Analytical Method Development (AMD) department. The aim is to ensure that all working standards used in analytical procedures are consistent, reliable, and traceable to a qualified primary or secondary reference standard.
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This SOP outlines the procedure for preparation, labeling, and usage of placebo formulations in analytical method development. Placebos are used for specificity, interference, and robustness assessments to ensure the reliability of the analytical procedure.
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This SOP defines the procedure for designing, validating, and documenting system suitability testing (SST) parameters during the analytical method development phase. System suitability ensures that the analytical system is functioning properly and can produce accurate and precise results prior to sample analysis.
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This SOP provides a systematic procedure for troubleshooting analytical methods that have been developed within the Analytical Method Development (AMD) department. The goal is to identify root causes of method-related failures or inconsistencies and implement corrective actions while maintaining data integrity and regulatory compliance.
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The purpose of this SOP is to establish a standardized procedure for the systematic review and approval of analytical method development data in the Analytical Method Development (AMD) department. This ensures that data generated during method development is accurate, complete, traceable, and meets regulatory expectations.
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This SOP outlines the procedure for development, evaluation, justification, and approval of non-pharmacopoeial test methods within the Analytical Method Development (AMD) department. It ensures that such methods are scientifically sound, validated appropriately, and aligned with regulatory expectations.
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This SOP describes the procedure for transferring analytical methods from the Analytical Method Development (AMD) department to receiving laboratories such as Quality Control (QC), contract research organizations (CROs), or manufacturing site labs. The goal is to ensure consistent method performance, data integrity, and compliance with regulatory expectations.
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This SOP describes the procedure for managing changes to analytical methods developed by the Analytical Method Development (AMD) department. The change control system ensures that all modifications are scientifically justified, appropriately reviewed, documented, and implemented in accordance with GMP and ICH Q10 guidelines.
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