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
- Develop the analytical method based on the intended purpose and regulatory requirements.
- Document method development studies, including the rationale for method selection, optimization, and preliminary performance characteristics.
4.2 Validation Protocol
- Prepare a validation protocol that outlines the scope, objectives, acceptance criteria, and procedures for method validation.
- Include parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, and robustness.
4.3 Validation Execution
- Perform validation studies according to the approved validation protocol.
- Conduct experiments to evaluate each validation parameter and record the results.
4.4 Validation Report
- Compile validation data, including raw data, calculations, and results, into a comprehensive validation report.
- Review and approve the validation report to confirm that the method meets the predefined acceptance criteria and regulatory requirements.
4.5 Routine Method Performance
- Monitor the performance of validated analytical methods during routine use.
- Perform periodic revalidation or method verification as necessary to ensure continued method reliability and compliance.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
6) Documents, if any
Validation Protocol, Validation Report, Method Development Report, Raw Data Sheets, Revalidation or Method Verification Reports
7) Reference, if any
Regulatory guidelines such as ICH Q2(R1) (Validation of Analytical Procedures: Text and Methodology), FDA Guidance for Industry: Analytical Procedures and Methods Validation, EMA guidelines
8) SOP Version
Version 1.0
