Standard Operating Procedure for Handling and Storage of Packaging Materials
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/240/2025 |
| Supersedes | SOP/TAB/240/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/05/2026 |
| Effective Date | 06/05/2026 |
| Review Date | 01/05/2027 |
1. Purpose
The purpose of this SOP is to outline the procedures for handling and storing packaging materials in a manner that ensures the integrity, quality, and compliance of these materials with Good Manufacturing Practices (GMP) and regulatory requirements.
2. Scope
This SOP applies to all packaging materials used for tablet products. It includes the receipt, inspection, storage, and handling of packaging materials until they are used in the manufacturing process.
3. Responsibilities
- Warehouse Manager: Ensures that packaging materials are stored in accordance with this SOP and that inventory levels are maintained appropriately.
- Warehouse Personnel: Responsible for the proper handling, storage, and stock rotation of packaging materials in the warehouse.
- Quality Control (QC) Inspector: Ensures the inspection of packaging materials upon receipt and verifies that they meet quality and regulatory standards.
- Production Manager: Coordinates with the warehouse to ensure timely availability of packaging materials for production.
4. Accountability
The Warehouse Manager is accountable for ensuring compliance with this SOP. The Quality Control department is responsible for inspecting the packaging materials, while the Production Manager oversees their use in the manufacturing process.
5. Procedure
5.1 Receiving and Inspection of Packaging Materials
- Upon receipt, packaging materials must be checked for compliance with the purchase order (PO) and quality specifications (Annexure-1).
- Ensure that packaging materials are free from damage, contamination, or defects. Perform visual inspections and sampling as required (Annexure-2).
- Verify that the materials are accompanied by the necessary documentation, including Certificate of Analysis (CoA) and supplier compliance certificates (Annexure-3).
5.2 Storage of Packaging Materials
- Store packaging materials in a designated area that is clean, dry, and free from any environmental conditions that may affect their quality (e.g., humidity, temperature) (Annexure-4).
- Ensure that packaging materials are stored off the floor and away from direct sunlight or extreme temperatures. Use shelves, pallets, or bins for proper storage (Annexure-5).
- Label storage areas clearly with the appropriate material identification and batch numbers (Annexure-6).
5.3 Stock Rotation
- Implement the First-In-First-Out (FIFO) system for packaging materials to ensure that older stock is used first (Annexure-7).
- Ensure that expired or damaged materials are segregated and properly disposed of (Annexure-8).
5.4 Handling of Packaging Materials
- Handle packaging materials with care to prevent damage during transfer or use. Ensure that personnel are trained in proper handling techniques (Annexure-9).
- If any packaging material is found to be damaged, report the issue immediately and document the incident (Annexure-10).
5.5 Documentation and Record-Keeping
- Maintain detailed records of packaging material receipt, inspection, and storage activities. All records must be accurate and traceable (Annexure-11).
- Ensure that all documentation, including CoAs, inspection logs, and material usage reports, are retained in compliance with regulatory and company policies (Annexure-12).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- CoA: Certificate of Analysis
- FIFO: First-In-First-Out
7. Documents
- Packaging Material Receipt Log (Annexure-1)
- Packaging Material Inspection Log (Annexure-2)
- Packaging Material Documentation Log (Annexure-3)
- Storage Area Log (Annexure-4)
- Packaging Material Storage Log (Annexure-5)
- Packaging Material Labeling Log (Annexure-6)
- Stock Rotation Log (Annexure-7)
- Damaged Material Report (Annexure-8)
- Packaging Material Handling Log (Annexure-9)
- Material Incident Log (Annexure-10)
- Packaging Material Record Log (Annexure-11)
- Material Documentation Retention Log (Annexure-12)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
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 Material Receipt Log
| Batch Number | Material | Receipt Date | Quantity Received | Supplier |
|---|---|---|---|---|
| Batch 12345 | Blister Pack | 01/05/2026 | 100,000 units | XYZ Suppliers |
Annexure-2: Packaging Material Inspection Log
| Material | Inspection Date | Inspector | Inspection Result | Comments |
|---|---|---|---|---|
| Blister Pack | 01/05/2026 | John Doe | Pass | No issues |
Annexure-3: Packaging Material Documentation Log
| Document Type | Document Reference Number | Issue Date | Document Status |
|---|---|---|---|
| Certificate of Analysis | COA-12345 | 01/05/2026 | Approved |
| Supplier Compliance Certificate | SC-12345 | 01/05/2026 | Approved |
Annexure-4: Storage Area Log
| Material | Storage Location | Temperature Range | Humidity Level | Storage Date |
|---|---|---|---|---|
| Blister Pack | Warehouse A, Shelf 3 | 15°C – 25°C | 45% – 60% | 01/05/2026 |
Annexure-5: Packaging Material Storage Log
| Material | Storage Start Date | Quantity Stored | Stored By | Inspection Date |
|---|---|---|---|---|
| Blister Pack | 01/05/2026 | 100,000 units | John Doe | 02/05/2026 |
Annexure-6: Packaging Material Labeling Log
| Material | Labeling Date | Labeling Operator | Batch Code | Label Status |
|---|---|---|---|---|
| Blister Pack | 01/05/2026 | Jane Smith | Batch 12345 | Completed |
Annexure-7: Stock Rotation Log
| Material | Stock Rotation Date | Operator | Batch Code Used | Action Taken |
|---|---|---|---|---|
| Blister Pack | 02/05/2026 | John Doe | Batch 12345 | Old stock used first |
Annexure-8: Damaged Material Report
| Material | Damage Type | Damage Description | Action Taken |
|---|---|---|---|
| Blister Pack | Crushed Boxes | Boxes were crushed during transport | Rejected and returned to supplier |
Annexure-9: Packaging Material Handling Log
| Material | Handling Date | Handled By | Action Taken |
|---|---|---|---|
| Blister Pack | 02/05/2026 | Jane Smith | Moved to the correct storage location |
Annexure-10: Material Incident Log
| Incident Type | Incident Date | Reported By | Action Taken |
|---|---|---|---|
| Material Damage | 02/05/2026 | John Doe | Rejected damaged material |
Annexure-11: Packaging Material Record Log
| Material | Received Date | Quantity Received | Batch Code | Supplier |
|---|---|---|---|---|
| Blister Pack | 01/05/2026 | 100,000 units | Batch 12345 | XYZ Suppliers |
Annexure-12: Material Documentation Retention Log
| Material | Document Type | Retention Period | Stored By |
|---|---|---|---|
| Blister Pack | Certificate of Analysis | 5 years | Jane Smith |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New procedure | QA Head |
| 01/05/2025 | 2.0 | Updated material storage procedure | Improved compliance | QA Head |