Standard Operating Procedure for Data Retention and Archiving

Purpose

The purpose of this SOP is to establish procedures for the systematic retention and secure archiving of electronic and paper-based data within the pharmaceutical manufacturing facility. This ensures compliance with regulatory standards and supports data integrity.

Scope

This SOP applies to all personnel involved in the manufacturing, quality control, and quality assurance of pharmaceutical products, including operators, technicians, and quality assurance personnel.

Responsibilities

• Data Stewards: Responsible for overseeing the data retention and archiving process within their respective areas.
• Quality Assurance Personnel: Responsible for conducting periodic reviews of data retention and archiving practices to ensure compliance with regulatory requirements.
• Operators and Technicians: Responsible for identifying data that requires archiving and ensuring proper documentation for archiving.

Procedure

1. Identification of Data for Archiving: Regularly assess and identify data that has reached the end of its useful life or regulatory-mandated retention period.
2. Documentation for Archiving: Prepare documentation specifying the data to be archived, including metadata such as the date, purpose, and relevant project or process details.
3. Secure Storage: Ensure that data designated for archiving is stored securely in compliance with confidentiality and data integrity requirements.
4. Archive Media: Choose appropriate media for archiving, considering factors such as data format, longevity, and ease of retrieval. Document the type of media used.
5. Labeling and Cataloging: Clearly label archived media with relevant details, including the date of archiving, the type of data, and any unique identifiers. Maintain a catalog or inventory of archived data.
6. Access Controls: Implement access controls to restrict access to archived data to authorized personnel only. Document and regularly review access permissions.
7. Retrieval Procedures: Establish procedures for retrieving archived data when needed for audits, regulatory inspections, or other legitimate purposes. Document the steps for retrieval.
8. Periodic Review: Conduct periodic reviews of archived data to assess its continued relevance and compliance with retention policies. Document the review findings.
9. Archiving of Paper-Based Records: For paper-based records, ensure proper storage conditions, including protection from environmental factors such as light, temperature, and humidity. Document the location and condition of paper archives.
10. Disposal of Archived Data: Develop procedures for the secure and compliant disposal of archived data when it reaches the end of its regulatory-mandated retention period. Document the disposal process.
11. Documentation of Archiving Activities: Maintain detailed records of all archiving activities, including documentation, labeling, and access controls. Archive these records as part of the data retention process.
12. Training: Ensure that personnel involved in data retention and archiving activities are trained on the procedures outlined in this SOP.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Data Retention and Archiving Logbook
• Archived Data Catalog
• Access Control Records
• Periodic Review Reports

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0