SOPs for Analytical Method Development V 2.0

This SOP describes the procedure for managing deviations that occur during analytical method development activities. It ensures proper identification, documentation, investigation, impact assessment, and closure in compliance with current Good Manufacturing Practices (cGMP) and quality system requirements.
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This SOP defines the procedure for preparing, implementing, and maintaining a skill-based training matrix for Analytical Method Development (AMD) department analysts. The matrix ensures analysts are appropriately trained, qualified, and authorized to perform assigned tasks in compliance with GMP, ICH Q10, and organizational standards.
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This SOP defines the standardized procedure for the qualification of instruments used in analytical method development (AMD). It ensures instruments are appropriately installed, operated, and performing as intended before their use in method development or validation, in alignment with GMP and ICH Q10 standards.
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This SOP describes the validation process for all software systems and computerized instruments used in the Analytical Method Development (AMD) laboratory to ensure they are suitable for their intended use, comply with regulatory guidelines, and safeguard data integrity.
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This SOP defines the procedure for performing and documenting the calibration of analytical instruments used in the Analytical Method Development (AMD) department to ensure reliable, reproducible, and accurate performance throughout the method development lifecycle.
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This SOP defines the procedure for qualifying reagents used in the Analytical Method Development (AMD) department. The aim is to ensure that all reagents used for method development and validation are appropriate for their intended use, traceable, and conform to applicable regulatory and GMP standards.
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This SOP outlines the principles and procedures required to ensure data integrity during analytical method development activities. It ensures that all data—whether electronic or paper-based—are accurate, complete, consistent, and secure throughout their lifecycle.
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This SOP describes the procedures for the issuance, utilization, review, and archival of Analytical Method Development (AMD) notebooks used to record method development trials, observations, and data. The objective is to ensure consistency, traceability, and compliance with ALCOA+ principles, GMP, and data integrity requirements.
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This SOP describes the procedure for the review, indexing, approval, and archiving of method development reports (MDRs) generated in the Analytical Method Development (AMD) department. It ensures secure storage, controlled access, and compliance with applicable regulatory and quality system requirements.
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This SOP establishes the framework for collaboration between the Analytical Method Development (AMD) department and the Product Development (PD) team. It ensures that analytical support is provided throughout the formulation and process development lifecycle, enhancing efficiency, quality, and regulatory compliance.
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