Standard Operating Procedure for Analytical Method Validation

1) Purpose

This SOP outlines the procedures for validating analytical methods used in the testing of pharmaceutical products to ensure their accuracy, precision, specificity, robustness, and compliance with regulatory requirements.

2) Scope

This SOP applies to all analytical methods used for the testing of raw materials, intermediates, active pharmaceutical ingredients (APIs), and finished products within the pharmaceutical manufacturing and quality control operations.

3) Responsibilities

The Analytical Development or Quality Control (QC) department is responsible for planning, executing, and documenting analytical method validation activities. Quality Assurance (QA) and other relevant departments are responsible for providing support and ensuring compliance with validation protocols.

4) Procedure

4.1 Method Development

1. Develop the analytical method based on the intended purpose and regulatory requirements.
2. Document method development studies, including the rationale for method selection, optimization, and preliminary performance characteristics.

4.2 Validation Protocol

1. Prepare a validation protocol that outlines the scope, objectives, acceptance criteria, and procedures for method validation.
2. Include parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, and robustness.

4.3 Validation Execution

1. Perform validation studies according to the approved validation protocol.
2. Conduct experiments to evaluate each validation parameter and record the results.

4.4 Validation Report

1. Compile validation data, including raw data, calculations, and results, into