SOPs for Analytical Method Development V 2.0

This SOP defines the process for managing Out-of-Trend (OOT) results encountered during analytical method development studies. The aim is to ensure early detection, systematic investigation, and resolution while maintaining data integrity and compliance with ICH, FDA, and WHO guidelines.
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The purpose of this SOP is to define the standardized process for the management of reference standards (RS) and working standards (WS) in the Analytical Method Development (AMD) department. This includes procurement, qualification, labelling, storage, usage, requalification, and destruction to ensure data integrity and regulatory compliance.
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This SOP defines the process for the qualification and requalification of volumetric and non-volumetric glassware used in the Analytical Method Development (AMD) department. It ensures accuracy in measurement and compliance with regulatory standards.
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The purpose of this SOP is to establish a standardized process for preparing and maintaining instrument calibration schedules to ensure instruments remain within valid calibration status and support data integrity in Analytical Method Development (AMD) operations.
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This SOP is intended to define the systematic procedure for the handling, recording, and disposal of expired primary reference standards and working standards used in the Analytical Method Development (AMD) laboratory. The aim is to ensure regulatory compliance, avoid inadvertent use, and minimize laboratory contamination risk.
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The purpose of this SOP is to define the procedure for the qualification of working standards (WS) used in analytical testing during method development, validation, and routine analysis. This includes preparation, characterization, documentation, and assignment of expiration or requalification periods.
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This SOP establishes a standardized method for calibrating the UV-Visible Spectrophotometer to ensure that it functions accurately and consistently, in compliance with cGMP and ICH guidelines.
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The purpose of this SOP is to establish a standard procedure for cleaning the sample preparation area in the Analytical Method Development (AMD) laboratory. This is critical to prevent contamination, ensure sample integrity, and maintain compliance with Good Laboratory Practices (GLP) and GMP requirements.
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The purpose of this SOP is to define a standard method for tracking all analytical samples received, processed, and reported within the Analytical Method Development (AMD) department. This ensures proper traceability, accountability, and regulatory compliance.
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The purpose of this SOP is to describe the procedures for conducting and evaluating system suitability tests (SST) to ensure the performance of chromatographic systems (HPLC, GC, UPLC) used in analytical method development meets defined criteria before or during analysis.
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