Procedure for Primary and Secondary Packaging
| Department | Packaging/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/093 |
| 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 primary and secondary packaging of ointments. This ensures compliance with Good Manufacturing Practices (GMP), product integrity, and regulatory requirements.
2. Scope
This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments involved in the primary and secondary packaging of ointments.
3. Responsibilities
- Packaging Operator: Performs primary and secondary packaging operations as per the batch packaging record (BPR).
- Packaging Supervisor: Ensures proper material usage and compliance with specifications.
- Quality Assurance (QA) Officer: Conducts in-process checks and verifies packaging quality.
- QA Manager: Approves the final packaged batch before release.
4. Accountability
The QA and Packaging Managers are accountable for ensuring that packaging operations meet GMP and regulatory requirements.
5. Procedure
5.1 Pre-Packaging Preparation
- Ensure that the packaging area is clean and ready for operations.
- Verify the availability of approved packaging materials as per the BPR.
- Check that equipment settings are correct for primary and secondary packaging.
5.2 Primary Packaging Process
- Load ointment tubes into the filling machine.
- Ensure that each tube receives the correct quantity of product.
- Seal tubes
properly and ensure no leakage.
Print batch number, expiry date, and manufacturing date on each tube.
5.3 Secondary Packaging Process
- Insert filled ointment tubes into cartons along with patient information leaflets (PILs).
- Ensure proper alignment and sealing of cartons.
- Apply tamper-evident labels and barcodes if required.
5.4 Inspection and Quality Control
- Perform random sampling of packaged products for quality checks.
- Verify label accuracy, seal integrity, and carton quality.
- QA must approve the packaged batch before dispatch.
5.5 Handling of Rejected Units
- Separate defective units and document reasons for rejection.
- Dispose of rejected units as per SOP for waste management.
- Record all rejected units in the Packaging Defect Log.
5.6 Documentation and Review
- Record packaging details in the Packaging Log.
- Ensure traceability of all packaged batches for regulatory compliance.
- QA must sign off on the final packaged batch before distribution.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BPR – Batch Packaging Record
7. Documents
- Packaging Inspection Log (Annexure-1)
- Final Packaging 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: Packaging Inspection Log
| Date | Batch Number | Packaging 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: Final Packaging Approval 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 |