Procedure for Assembling Packing Materials
| Department | Packaging/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/091 |
| 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 guidelines for assembling packing materials for ointment packaging. Proper assembly ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and product integrity.
2. Scope
This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for selecting, verifying, and assembling packing materials before the packaging process.
3. Responsibilities
- Packaging Operator: Collects, inspects, and assembles packing materials.
- Packaging Supervisor: Ensures correct materials are issued and assembled as per batch records.
- Quality Assurance (QA) Officer: Verifies material integrity and compliance with specifications.
- QA Manager: Reviews and approves final packing material documentation.
4. Accountability
The QA and Packaging Managers are accountable for ensuring that packing materials meet quality and regulatory standards before packaging begins.
5. Procedure
5.1 Pre-Assembling Checks
- Ensure that the packaging area is clean and free from previous batch materials.
- Verify that the correct packaging materials are available for the assigned batch.
- Check that the required packing components (tubes, cartons, labels, inserts) are in good condition.
5.2 Packing Material Verification
- Compare received packing materials against the Batch Packaging Record (BPR).
- Ensure that labels
match product specifications, including batch number and expiry date.
Confirm that packaging materials are free from damage or contamination.
5.3 Assembling Packing Components
- Arrange primary packaging materials (e.g., ointment tubes) in the correct sequence.
- Verify the presence of secondary packaging components (e.g., cartons, inserts).
- Ensure that tamper-evident seals and batch-coded labels are available.
5.4 Documentation and Review
- Record all assembled packing materials in the Packaging Material Log.
- QA must verify assembled materials before final packaging begins.
- Any discrepancies must be documented, investigated, and resolved before proceeding.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BPR – Batch Packaging Record
7. Documents
- Packing Material Inspection Log (Annexure-1)
- Batch Packaging 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: Packing Material Inspection Log
| Date | Batch Number | Packing 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: Batch Packaging Verification 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 |