Procedure for Documentation of Packed Batches

Department	Packaging/Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/099
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 define the procedure for documenting packed batches of ointments. This ensures proper batch traceability, regulatory compliance, and adherence to Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for recording, verifying, and maintaining documentation for packed batches.

3. Responsibilities

• Packaging Operator: Records packaging details in the Batch Packaging Record (BPR).
• Packaging Supervisor: Reviews batch documentation for completeness and accuracy.
• Quality Assurance (QA) Officer: Verifies documentation and approves batch records.
• QA Manager: Ensures all documentation complies with regulatory and GMP standards.

4. Accountability

The QA and Packaging Managers are accountable for maintaining accurate records of packed batches before final product release.

5. Procedure

5.1 Pre-Packaging Documentation

• Ensure that the Batch Packaging Record (BPR) is available before starting the packaging process.
• Verify that batch numbers, expiry dates, and packaging materials match the approved specifications.
• Confirm that line clearance has been performed and documented.

5.2 In-Process Documentation

• Record packaging line operations, including batch start and end times.
• Document equipment settings, packaging material usage, and process parameters.
• Ensure that packaging defects and corrective actions are recorded.

5.3 Post-Packaging Documentation

• Complete the final batch reconciliation, ensuring the correct quantity of packed units.
• Record the disposal of excess or rejected packaging materials.
• QA must verify and sign off on completed batch documentation.

5.4 Storage and Record Retention

• Store batch records in a secure, designated area for regulatory inspections.
• Ensure records are maintained for the required retention period as per regulatory guidelines.
• Provide documentation access to authorized personnel only.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BPR – Batch Packaging Record

7. Documents

• Batch Packaging Record (Annexure-1)
• Final Batch Documentation Approval Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q10 – Pharmaceutical Quality System
• USP <41> – Weights and Balances

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Packaging Record

Date	Batch Number	Packaging Material Used	Operator Name	Reviewed By	Remarks
01/02/2025	OINT-101	Cartons, Tubes, Labels	Packaging Operator	QA Officer	Compliant
01/02/2025	OINT-102	Cartons, Seals	Packaging Operator	QA Officer	Compliant

Annexure-2: Final Batch Documentation Approval Report

Date	Batch Number	Document Type	Verified By	Approval Status
01/02/2025	OINT-101	Batch Packaging Record	QA Manager	Approved
02/02/2025	OINT-102	Batch Packaging Record	QA Manager	Approved

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head