Procedure for Archiving Ointment Manufacturing Records

Department	Quality Assurance (QA)/Quality Control (QC)/Production
SOP No.	SOP/Ointment/160
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for archiving ointment manufacturing records. Proper archiving ensures compliance with Good Manufacturing Practices (GMP), facilitates audits, and maintains traceability of batch production records, test reports, and regulatory documents.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for maintaining, reviewing, and archiving ointment manufacturing records in both physical and electronic formats.

3. Responsibilities

• Production Officer: Ensures manufacturing records are compiled and submitted for archiving.
• QC Analyst: Provides laboratory test reports and analytical data for archiving.
• QA Officer: Reviews records for completeness and compliance before archiving.
• QA Manager: Approves the archiving of records and ensures compliance with regulatory retention policies.

4. Accountability

The QA and Production Managers are accountable for ensuring that all ointment manufacturing records are properly archived and maintained for the required retention period.

5. Procedure

5.1 Types of Ointment Manufacturing Records for Archiving

The following records must be archived:

• Batch Manufacturing Records (BMR): Contains details of batch processing, raw material usage, and in-process controls.
• Quality 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