Developing Analytical Methods in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing analytical methods during the formulation development process, ensuring robust methods for assessing product quality and performance.

2) Scope

This SOP applies to all formulation development projects within the organization, covering analytical method development activities from method selection to validation and implementation.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing analytical method development activities and ensuring alignment with project objectives and timelines.
Analytical Development Scientist: Conducting method development experiments and optimizing analytical techniques.
Quality Assurance: Reviewing and approving method development protocols, validation plans, and final method validation reports.
Regulatory Affairs: Ensuring analytical methods meet regulatory requirements and supporting submissions.

4) Procedure

4.1 Method Selection and Feasibility Study

1. Identify analytical requirements based on product characteristics, regulatory guidelines, and intended use.
2. Conduct literature review and feasibility studies to select appropriate analytical techniques.
3. Assess method feasibility in terms of sensitivity, specificity, accuracy, precision, and robustness.

4.2 Method Development

1. Design experimental protocols for method development, including experimental design and acceptance criteria.
2. Optimize analytical parameters (e.g., mobile phase composition, detection wavelength) to achieve desired method performance.
3. Document method development activities, results, and rationale for method selection.

4.3 Method Validation

1. Develop a validation protocol outlining validation parameters, acceptance criteria, and experimental procedures.
2. Validate analytical methods according to International Conference on Harmonisation (ICH) guidelines or applicable regulatory standards.
3. Perform validation experiments, including specificity, linearity, accuracy, precision, and robustness studies.

4.4 Method Transfer and Implementation

1. Transfer validated methods to quality control or analytical testing laboratories as applicable.
2. Provide training to analysts on the use and application of developed and validated analytical methods.
3. Verify method performance and suitability in routine analysis through method verification studies.

4.5 Method Documentation and Reporting

1. Prepare comprehensive method development and validation reports summarizing experimental data, results, and conclusions.
2. Obtain review and approval of method development and validation reports from designated approvers.
3. Archive final method validation reports and related documentation for future reference and regulatory inspections.

5) Abbreviations, if any

SOP: Standard Operating Procedure
ICH: International Conference on Harmonisation

6) Documents, if any

Method Development Protocols
Validation Protocols and Reports
Method Transfer Documents
Method Validation Summaries

7) Reference, if any

– ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology
– FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics

8) SOP Version

Version 1.0