SOP for Overwrapping and Shrink-Wrapping – V 2.0

Procedure for Overwrapping and Shrink-Wrapping

Department	Packaging/Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/095
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 proper method for performing overwrapping and shrink-wrapping of ointment packaging to ensure product protection, tamper evidence, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for overwrapping and shrink-wrapping finished ointment products.

3. Responsibilities

Packaging Operator: Conducts overwrapping and shrink-wrapping according to standard procedures.
Packaging Supervisor: Ensures correct setup, operation, and monitoring of wrapping equipment.
Quality Assurance (QA) Officer: Inspects wrapped products and ensures compliance with specifications.
QA Manager: Approves the final wrapped batch before distribution.

4. Accountability

The QA and Packaging Managers are accountable for ensuring overwrapping and shrink-wrapping operations comply with GMP and regulatory requirements.

5. Procedure

5.1 Pre-Wrapping Preparations

Ensure the packaging area is clean and free from previous batch materials.
Verify that the correct wrapping material (e.g., shrink film, overwrap) is available.
Check that the shrink-wrapping machine is properly calibrated and functional.

5.2 Overwrapping Process

Place finished ointment cartons in the designated overwrapping area.
Ensure that the correct wrapping material is used as per batch packaging specifications.
Manually or mechanically wrap the batch with the overwrapping film.
Ensure uniform wrapping without air gaps or wrinkles.

5.3 Shrink-Wrapping Process

Feed the overwrapped products into the shrink-wrapping tunnel.
Set the temperature and speed parameters of the shrink-wrapping machine.
Ensure that shrink-wrapping evenly adheres to the product without causing deformation.
Perform random checks for proper seal formation and wrapping integrity.

5.4 Quality Inspection

Conduct visual inspection to ensure no torn or improperly sealed wraps.
Ensure that batch numbers and expiry dates remain visible after shrink-wrapping.
QA must verify that wrapped products meet specifications before final approval.

5.5 Handling of Defective Wrapping

Identify and segregate improperly wrapped units.
Document and investigate the cause of wrapping defects.
Reprocess or discard defective wrapped products as per QA decision.

5.6 Documentation and Review

Record shrink-wrapping details in the Packaging Log.
QA must review and approve the final wrapped batch before storage or dispatch.
Ensure traceability of wrapped batches for regulatory compliance.

6. Abbreviations

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

7. Documents

Overwrapping and Shrink-Wrapping Inspection Log (Annexure-1)
Final Shrink-Wrapping 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: Overwrapping and Shrink-Wrapping Inspection Log

Date	Batch Number	Wrapping Type	Inspected By	Result	Remarks
01/02/2025	OINT-101	Shrink-Wrap	QA Officer	Pass	Compliant
01/02/2025	OINT-102	Overwrap	QA Officer	Pass	Compliant

Annexure-2: Final Shrink-Wrapping Approval Report

Date	Batch Number	Wrapping Component	Verified By	Approval Status
01/02/2025	OINT-101	Shrink Film, Labels	QA Manager	Approved
02/02/2025	OINT-102	Overwrap, Carton Labels	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