Analytical Method Validation is required for analysis of pharmaceutical products falling under the scope of Good Manufacturing Practices (GMPs) as outlined in 21 CFR 210/211. Validated analytical methods are used in chemical characterization, Quality Control testing, and in support of manufacturing batch records for manufactured and packaged pharmaceuticals. A validated analytical method ensures that pharmaceutical analysis for quantitative and qualitative determination of Active Pharmaceutical Ingredients (APIs) or drug substances, drug formulations, and bulk and finished drug products will be reliable, rugged, and repeatable.
Analytical method validation relies on more than accuracy, precision, and repeatability. Regulatory focus is shifting to a lifecycle approach for method validation, which reflects how the method will integrate with its intended operating environment and includes provisions for continued monitoring and improvement. The method becomes a functional unit of your whole quality system. Qualified facilities and equipment, validated systems, and properly-trained personnel are the foundation of high-quality method performance. By linking the method validation project to your Validation Master Plan, all elements of your quality program can be cited in direct support of your method validation activities.
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