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 |