Analytical Method Lifecycle Management SOP
3 800 Skr
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Purpose:
This SOP defines the governance and lifecycle management of analytical methods, including development, validation, transfer, verification, change management, and periodic review, to ensure continued suitability for intended use.
Regulatory Alignment:
EU GMP requirements for quality control and analytical methods, aligned with principles outlined in ICH Q2 and ICH Q14 guidance.
Included Files:
• SOP – Analytical Method Lifecycle Management
• Analytical method lifecycle overview and responsibility matrix
• Method change and periodic review templates
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical manufacturers, contract manufacturing organisations, quality control laboratories, analytical development teams, and quality assurance personnel responsible for GMP analytical method governance.