SOPs for Analytical Method Development V 2.0

The purpose of this SOP is to describe the procedure for the qualification of analytical balances used in the Analytical Method Development (AMD) laboratory. This includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure balance reliability, accuracy, and GMP compliance.
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The purpose of this SOP is to define a standardized procedure for identifying, documenting, analyzing, and addressing failures that occur during analytical method development (AMD) activities. The objective is to ensure continuous improvement, compliance with regulatory expectations, and scientific justification of failures and their resolutions.
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The purpose of this SOP is to establish a structured process for identifying, evaluating, and documenting Out-of-Trend (OOT) results observed during Analytical Method Development (AMD) activities. The goal is to ensure data integrity, GMP compliance, and a robust scientific rationale for handling such events.
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The purpose of this SOP is to establish a systematic approach for the control, review, and secure archival of chromatographic data generated during analytical method development. This ensures data integrity, traceability, compliance with cGMP regulations, and supports regulatory inspections and audits.
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This SOP defines the systematic approach for handling unplanned instrument downtime in the Analytical Method Development (AMD) laboratory. The objective is to ensure continuity of critical activities, minimize impact on analytical schedules, and maintain GMP compliance through proper documentation, communication, and risk assessment.
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The purpose of this SOP is to outline the procedures for the handling, qualification, storage, and use of primary and secondary reference standards in the Analytical Method Development (AMD) laboratory. Proper management of reference standards is critical to ensure accuracy, traceability, and regulatory compliance.
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This SOP defines the standard procedure for evaluating system suitability parameters before initiating sample analysis during analytical method development and validation. System suitability ensures the integrity of the chromatographic system and accuracy of analytical results.
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This SOP provides a standardized approach for selecting appropriate chromatographic conditions including stationary phase, mobile phase composition, flow rate, detection parameters, and temperature settings to ensure optimal separation, sensitivity, and reproducibility during analytical method development.
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The purpose of this SOP is to establish a systematic procedure for the handling, qualification, storage, usage, and documentation of analytical reference standards used in method development and validation processes. This ensures traceability, integrity, and compliance with regulatory requirements.
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This SOP describes the standard procedure for calibration of UV-Visible spectrophotometers to ensure accurate, precise, and reliable performance in analytical method development. It includes wavelength accuracy, photometric accuracy, stray light, resolution, and baseline flatness checks.
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