Analytical Method Reporting in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for reporting analytical methods developed during analytical method development, ensuring clear documentation and communication of method details.

2) Scope

This SOP applies to all personnel involved in reporting analytical methods developed 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 analytical method reporting.

4) Procedure

1. Documentation Requirements:
   1. Document all essential details of the developed analytical method, including parameters, conditions, and validation outcomes.
   2. Ensure completeness and accuracy of method documentation.
2. Format and Structure:
   1. Follow a standardized format for reporting analytical methods, including title, objective, scope, method details, and validation summary.
   2. Include clear and concise descriptions of experimental procedures and data interpretation.
3. Review and Approval:
   1. Review the method report for accuracy, completeness, and compliance with internal standards and regulatory requirements.
   2. Obtain necessary approvals from designated personnel or stakeholders before dissemination or implementation.
4. Archiving and Version Control:
   1. Archive approved method reports in a secure and accessible manner.
   2. Maintain version control to track revisions and updates to method documentation.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to analytical method reporting in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Analytical Method Reports
• Review and Approval Records
• Archived Method Documentation
• Version Control Records

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q2(R1): Validation of Analytical Procedures
• USP General Chapter Validation of Compendial Methods

8) SOP Version

Version 1.0