Standard Operating Procedure for Analytical Method Development for Granules

1) Purpose

The purpose of this SOP is to outline the procedures for the development of analytical methods for granule formulations in the pharmaceutical industry, ensuring accuracy, precision, and compliance with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the development of analytical methods for granule formulations within the pharmaceutical research and development (R&D) and quality control (QC) departments.

3) Responsibilities

Research and Development (R&D) Department: Responsible for designing and developing analytical methods.
Quality Control (QC) Department: Responsible for validating and implementing analytical methods.
Quality Assurance (QA) Department: Responsible for reviewing and approving analytical methods and validation reports.

4) Procedure

1. Literature Review and Method Selection:
   1. Conduct a comprehensive literature review to identify existing analytical methods for similar granule formulations.
   2. Select potential methods based on the API, excipients, and desired analytical parameters.
2. Method Development:
   1. Prepare standard solutions and calibration curves for the API and any relevant impurities.
   2. Optimize analytical parameters such as wavelength, flow rate, column type, and mobile phase composition for chromatographic methods.
   3. Develop sample preparation procedures, including dissolution, extraction, and filtration techniques.
3. Preliminary Testing:
   1. Conduct preliminary testing using the developed method to assess its suitability for the intended purpose.
   2. Evaluate key parameters such as accuracy, precision, linearity, specificity, and sensitivity.
4. Method Optimization:
   1. Optimize the method based on preliminary testing results to improve performance and reliability.
   2. Adjust parameters and procedures as necessary to achieve the desired analytical quality.
5. Method Validation:
   1. Conduct full method validation according to ICH guidelines, including assessments of accuracy, precision, linearity, range, specificity, robustness, and detection/quantitation limits.
   2. Prepare a validation report documenting all validation activities, results, and conclusions.
6. Documentation and Implementation:
   1. Document the final analytical method, including detailed procedures, parameters, and acceptance criteria.
   2. Implement the validated method in the QC department for routine analysis.
   3. Train QC personnel on the new method and ensure proper understanding and execution.
7. Continuous Monitoring and Improvement:
   1. Monitor the performance of the analytical method during routine use to identify any issues or areas for improvement.
   2. Make necessary adjustments and improvements to the method based on ongoing performance data and feedback.

5) Abbreviations, if any

SOP: Standard Operating Procedure
R&D: Research and Development
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
ICH: International Conference on Harmonisation

6) Documents, if any

Literature Review Records, Method Development Records, Method Validation Reports

7) Reference, if any

ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology.

8) SOP Version

Version 1.0