Procedure for Assembling Packing Materials

Department	Packaging/Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/091
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 guidelines for assembling packing materials for ointment packaging. Proper assembly ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and product integrity.

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for selecting, verifying, and assembling packing materials before the packaging process.

3. Responsibilities

• Packaging Operator: Collects, inspects, and assembles packing materials.
• Packaging Supervisor: Ensures correct materials are issued and assembled as per batch records.
• Quality Assurance (QA) Officer: Verifies material integrity and compliance with specifications.
• QA Manager: Reviews and approves final packing material documentation.

4. Accountability

The QA and Packaging Managers are accountable for ensuring that packing materials meet quality and regulatory standards before packaging begins.

5. Procedure

5.1 Pre-Assembling Checks

• Ensure that the packaging area is clean and free from previous batch materials.
• Verify that the correct packaging materials are available for the assigned batch.
• Check that the required packing components (tubes, cartons, labels, inserts) are in good condition.

5.2 Packing Material Verification

• Compare received packing materials against the Batch Packaging Record (BPR).
• Ensure that labels match product specifications, including batch number and expiry date.
• Confirm that packaging materials are free from damage or contamination.

5.3 Assembling Packing Components

• Arrange primary packaging materials (e.g., ointment tubes) in the correct sequence.
• Verify the presence of secondary packaging components (e.g., cartons, inserts).
• Ensure that tamper-evident seals and batch-coded labels are available.

5.4 Documentation and Review

• Record all assembled packing materials in the Packaging Material Log.
• QA must verify assembled materials before final packaging begins.
• Any discrepancies must be documented, investigated, and resolved before proceeding.

6. Abbreviations

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

7. Documents

• Packing Material Inspection Log (Annexure-1)
• Batch Packaging Verification 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: Packing Material Inspection Log

Date	Batch Number	Packing Component	Inspected By	Result	Remarks
01/02/2025	OINT-101	Tubes	QA Officer	Pass	Compliant
01/02/2025	OINT-102	Cartons	QA Officer	Pass	Compliant

Annexure-2: Batch Packaging Verification Report

Date	Batch Number	Packaging Component	Verified By	Approval Status
01/02/2025	OINT-101	Tubes, Labels, Cartons	QA Manager	Approved
02/02/2025	OINT-102	Inserts, Cartons	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