Developing Physical Testing Methods for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing physical testing methods during the analytical method development process, ensuring accurate characterization of physical properties of pharmaceutical formulations.

2) Scope

This SOP applies to all personnel involved in developing physical testing methods for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in developing physical testing methods.

4) Procedure

1. Method Development Objectives:
   1. Define objectives for developing physical testing methods based on product specifications and intended use.
   2. Identify physical properties to be tested (e.g., hardness, friability, disintegration).
2. Selection of Testing Equipment:
   1. Evaluate and select appropriate testing equipment based on test requirements and sample characteristics.
   2. Ensure equipment calibration and validation as per regulatory requirements.
3. Method Development and Optimization:
   1. Develop and optimize testing methods to ensure accurate and reproducible results.
   2. Establish method parameters such as test conditions, sample preparation, and acceptance criteria.
4. Validation of Physical Testing Methods:
   1. Validate physical testing methods according to regulatory guidelines and predefined acceptance criteria.
   2. Document validation results and conclusions regarding method suitability for physical property characterization.
5. Documentation and Reporting:
   1. Document all physical testing method development activities, including objectives, equipment selection, method development, and validation.
   2. Prepare a physical testing method development report summarizing method development activities and outcomes.
6. Review and Approval:
   1. Review the physical testing method development report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the physical testing method development report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to physical testing method development for analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Physical Testing Method Development Report
• Validation Results Documentation
• Equipment Calibration Records
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• USP General Chapters relevant to specific physical tests (e.g., hardness, disintegration)
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0