Reports: Analytical results, stability data, and out-of-specification (OOS) reports.

Regulatory Documents: Product registration files, submissions, and compliance reports.

Deviation and CAPA Reports: Records of process deviations and corrective/preventive actions.

Training Records: Documentation of personnel training and competency assessments.

Equipment Calibration and Maintenance Logs: Ensures traceability of equipment qualification.

Environmental Monitoring Data: Records of temperature, humidity, microbial load, and particulate counts.

5.2 Data Archiving Methods

Archiving may be done in either physical (paper-based) or electronic formats, based on company policy.

• Physical Archiving:
  • Paper documents must be stored in fireproof, locked cabinets.
  • Archived documents must be labeled with unique identification numbers.
  • Storage areas must be climate-controlled and protected from moisture.
• Electronic Archiving:
  • Data must be stored in a **validated Document Management System (DMS).**
  • Backups must be performed on **secure servers with restricted access.**
  • Electronic signatures must comply with **21 CFR Part 11** for regulatory acceptance.

5.3 Data Retention Period

• All data must be archived for the following minimum durations:
  • Batch Manufacturing Records: **At least 5 years after product expiration.**
  • QC Analytical Data: **At least 7 years.**
  • Regulatory Documents: **At least 10 years.**
  • Equipment Calibration Logs: **At least 5 years.**
  • Training Records: **At least 3 years post-employment.**
• Records must be accessible for regulatory inspections at all times.

5.4 Security and Access Control

• Archived data must have **restricted access** based on role-based permissions.
• QA and Regulatory Affairs personnel must approve any **data retrieval requests.**
• Access to electronic archives must require **password authentication and audit logging.**
• Physical archives must be protected with **authorized key or badge entry.**

5.5 Data Backup and Disaster Recovery

• Electronic archives must have:
  • Daily incremental backups.
  • Weekly full backups stored on secure cloud or off-site locations.
  • Data recovery testing performed **annually.**
• Paper-based archives must have **duplicate copies stored off-site** for critical records.
• Emergency recovery plans must be documented and reviewed **every six months.**

5.6 Periodic Review and Audit of Archived Data

• QA and IT must conduct **quarterly audits** of archived records.
• All archived data must be verified for completeness and compliance.
• Non-compliant records must be corrected within **15 days** of identification.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• DMS – Document Management System
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Data Archiving Log (Annexure-1)
• Data Retrieval Request Form (Annexure-2)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO Guidelines on Data Integrity and Archiving
• US FDA 21 CFR Part 11 – Electronic Records and Signatures

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Data Archiving Log

Date	Document Type	Retention Period	Storage Location	QA Approval
02/02/2025	Batch Record	5 Years	Secured Archive	Approved

Annexure-2: Data Retrieval Request Form

Date	Requester Name	Document Type	Purpose	Approval Status
02/02/2025	Jane Smith	QC Test Report	Regulatory Audit	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Archiving Security Measures	Improved Compliance	QA Head