Control Test Reports: Includes analytical and microbial test results for raw materials, intermediates, and finished products.

Cleaning and Sanitation Records: Documents cleaning schedules for equipment and manufacturing areas.

Deviation and CAPA Reports: Contains information on any process deviations and corrective actions taken.

Validation and Qualification Reports: Includes process validation, equipment qualification, and stability study reports.

Regulatory Submission Documents: Includes regulatory approvals, compliance certificates, and audit reports.

5.2 Record Compilation and Review

• All manufacturing records must be compiled within **7 days** of batch completion.
• QA must review each record for:
  • Completeness of entries.
  • Signatures and authorizations.
  • Accuracy and compliance with GMP requirements.
• Any missing or incorrect entries must be corrected before archiving.

5.3 Record Categorization and Labeling

• Records must be categorized into **paper-based and electronic formats.**
• Each record must be labeled with:
  • Record type (e.g., BMR, QC Report, Validation Report).
  • Batch Number.
  • Retention Period.
  • Storage Location.

5.4 Physical Archiving of Paper Records

• Paper records must be stored in a **fireproof, humidity-controlled archive room**.
• Records must be stored in **labeled storage boxes** arranged systematically by:
  • Batch Number.
  • Year of Manufacture.
  • Record Type.
• Access to the archive must be **restricted** to authorized personnel only.
• A **record retrieval log** must be maintained to track document access.

5.5 Electronic Archiving of Records

• All electronic records must be stored in a **validated document management system (DMS).**
• Electronic records must be:
  • Scanned in **PDF format** for long-term preservation.
  • Digitally signed for authenticity.
  • Backed up on **secured servers** with controlled access.
• Audit trails must be enabled to track any modifications or access.
• Records must be periodically checked for **file integrity and readability.**

5.6 Retention Period and Disposal of Archived Records

• Retention periods must comply with **GMP and regulatory guidelines**:
• Batch Manufacturing Records – **Minimum 5 years**.
• QC Test Reports – **Minimum 7 years**.
• Validation Documents – **Minimum 10 years**.
• Regulatory Compliance Records – **Permanent Storage**.
• Records past the retention period must be **disposed of securely** following approval from QA.
• Record disposal must be documented in a **Record Destruction Log.**

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• CAPA – Corrective and Preventive Action
• DMS – Document Management System
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Record Retrieval Log (Annexure-1)
• Record Destruction Log (Annexure-2)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO Guidelines on Document Retention
• US FDA Guidance on Archiving and Record Management

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Record Retrieval Log

Date	Document Type	Batch No.	Retrieved By	Purpose	Returned Date
02/02/2025	BMR	OINT-1001	John Doe	Audit Review	05/02/2025

Annexure-2: Record Destruction Log

Date	Document Type	Batch No.	Destruction Method	QA Approval
02/02/2030	QC Test Reports	OINT-1001	Shredding	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Procedure	Improved Record Retention Policies	QA Head