Procedure for Labeling Ointment Containers
| Department | Packaging/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/092 |
| 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 method for labeling ointment containers to ensure accuracy, compliance with regulatory requirements, and Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for verifying, applying, and inspecting labels on ointment containers.
3. Responsibilities
- Packaging Operator: Ensures labels are correctly affixed to ointment containers.
- Packaging Supervisor: Monitors the labeling process and ensures compliance with specifications.
- Quality Assurance (QA) Officer: Verifies labeling accuracy and batch records.
- QA Manager: Approves the final labeled batch before release.
4. Accountability
The QA and Packaging Managers are accountable for ensuring that labeling operations comply with GMP standards and regulatory requirements.
5. Procedure
5.1 Pre-Labeling Checks
- Ensure that the packaging area is clean and free from previous batch materials.
- Verify that the correct labels are available as per the Batch Packaging Record (BPR).
- Confirm that the printing machine is set to the correct batch number, expiry date, and manufacturing date.
5.2 Labeling Process
- Adjust the labeling machine for proper label alignment.
- Ensure that each ointment container receives only one label.
- Monitor the label application process to prevent misalignment or wrinkling.
5.3 Inspection and Verification
- Perform a random sampling of labeled containers to verify label placement and adherence.
- Check for smudging, misprints, or missing information.
- QA must verify that all label information matches the batch records.
5.4 Handling of Defective Labels
- Separate and document any incorrectly labeled containers.
- Report labeling defects to the Packaging Supervisor and QA.
- Ensure that rejected labels are disposed of properly.
5.5 Documentation and Review
- Record all labeling activities in the Labeling Log.
- QA must approve the labeled batch before further packaging.
- Maintain all documentation for traceability and audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BPR – Batch Packaging Record
7. Documents
- Labeling Inspection Log (Annexure-1)
- Batch Labeling 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: Labeling Inspection Log
| Date | Batch Number | Labeling Machine Used | Inspected By | Result | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | LM-01 | QA Officer | Pass | Compliant |
| 01/02/2025 | OINT-102 | LM-02 | QA Officer | Pass | Compliant |
Annexure-2: Batch Labeling Verification Report
| Date | Batch Number | Labeling Component | Verified By | Approval Status |
|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Labels, Batch Codes | QA Manager | Approved |
| 02/02/2025 | OINT-102 | Carton Labels, Inserts | 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 |