Procedure for QA Oversight During Packing Operations
| Department | Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/085 |
| 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 standardized process for Quality Assurance (QA) oversight during packing operations in ointment manufacturing. This ensures that the packaging process meets Good Manufacturing Practices (GMP) requirements and that finished products comply with regulatory standards.
2. Scope
This SOP applies to all personnel in the QA and Production departments responsible for monitoring, verifying, and ensuring compliance with packing operations for ointment products.
3. Responsibilities
- QA Officer: Conducts in-process checks and ensures packing process adherence to standards.
- Production Operator: Performs packing operations according to approved procedures.
- Production Supervisor: Oversees packing operations and ensures compliance with QA guidelines.
- QA Manager: Reviews and approves packing records and ensures compliance with GMP regulations.
4. Accountability
The QA and Production Managers are accountable for ensuring that all packing operations are conducted as per regulatory requirements and that product integrity is maintained.
5. Procedure
5.1 Pre-Packing QA Checks
- Ensure that the packing area is clean and ready for operations.
- Verify that packing materials (tubes, cartons, labels) are QA-approved.
- Ensure that batch records and product specifications are available.
5.2 In-Process QA Oversight
5.2.1 Verification of Packing Materials
- Confirm that the correct batch number, expiry date, and manufacturing date are printed on packaging.
- Check that the correct labels and patient information leaflets are used.
5.2.2 Filling and Sealing Inspection
- Ensure that filled containers meet specified weight/volume requirements.
- Check for proper sealing of tubes to prevent leakage.
- Monitor random samples to confirm consistency in filling.
5.2.3 Labeling and Printing Verification
- Verify that labels are correctly aligned and securely affixed.
- Ensure that barcode and serialization numbers are correct.
- Check for smudging or misprints on labels.
5.2.4 Final Packing Inspection
- Ensure that packed units are uniform and meet appearance standards.
- Check for damaged or defective packaging materials.
- Verify the reconciliation of packing components.
5.3 Post-Packing QA Review
- Perform final verification of packed batch against specifications.
- Ensure that rejected units are properly documented and removed.
- QA must approve the packed batch before release for distribution.
5.4 Documentation
- Record all QA oversight activities in the Packing Oversight Log.
- Document any deviations and corrective actions taken.
- Ensure traceability by maintaining batch-wise records.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Packing Oversight Log (Annexure-1)
- Packing Batch 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: Packing Oversight Log
| Date | Batch Number | Packing Step | Observation | Deviation (if any) | Corrective Action | Verified By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Filling | Volume: 30 g | None | NA | QA Officer |
| 01/02/2025 | OINT-102 | Labeling | Printing clear | None | NA | QA Officer |
Annexure-2: Packing Batch Approval Report
| Date | Batch Number | Product Name | Final QA Check | Approval Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Ointment A | Pass | Approved | QA Head |
| 02/02/2025 | OINT-102 | Ointment B | Pass | Approved | QA Head |
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 |