Data Integrity in Analytical Methods Development

1) Purpose

The purpose of this SOP is to outline the procedure for ensuring data integrity throughout the development, validation, and implementation of analytical methods in compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in analytical method development and validation within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in maintaining data integrity in analytical methods.

4) Procedure

1. Data Handling and Recording:
   1. Define procedures for accurate and reliable data recording during method development and validation.
   2. Implement controls to prevent data manipulation, unauthorized access, or loss.
2. Documentation Practices:
   1. Document all experimental data, observations, and results in real-time using approved templates or electronic systems.
   2. Ensure data entries are complete, accurate, and traceable to the source.
3. Review and Approval:
   1. Establish procedures for reviewing and approving analytical data, including verification of data integrity and compliance with procedures.
   2. Document review and approval activities to demonstrate accountability and compliance.
4. Data Storage and Retention:
   1. Store analytical data in secure, accessible, and organized formats to facilitate retrieval and audit trail.
   2. Establish retention periods and procedures for archival of analytical records.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to data integrity in analytical methods development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Data Integrity Procedures
• Data Handling and Recording Templates
• Review and Approval Records
• Data Storage and Retention Policies

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

8) SOP Version

Version 1.0