Standard Operating Procedure for Preventing Mix-Ups in Packaging Areas
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/242/2025 |
| Supersedes | SOP/TAB/242/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/07/2026 |
| Effective Date | 06/07/2026 |
| Review Date | 01/07/2027 |
1. Purpose
The purpose of this SOP is to outline the procedures and practices to prevent mix-ups during the packaging process. It ensures that products are correctly labeled, packaged, and stored in compliance with GMP and regulatory requirements, avoiding cross-contamination or mistakes in product identification.
2. Scope
This SOP applies to all packaging processes for tablet products, including primary and secondary packaging operations. It covers procedures for material handling, labeling, storage, and packaging to prevent mix-ups in the packaging areas.
3. Responsibilities
- Packaging Operators: Responsible for following packaging instructions accurately, ensuring that the correct materials and products are used, and reporting any discrepancies immediately.
- Production Manager: Ensures that the packaging process is carried out as per the SOP, monitors the packaging area for potential risks, and coordinates corrective actions if needed.
- Quality Control (QC) Team: Conducts periodic inspections to verify the accuracy of the packaging process, labels, and stored materials to ensure compliance with standards.
- Warehouse Manager: Ensures that packaging materials are properly stored and segregated to avoid mix-ups and that batch records are accurately maintained.
4. Accountability
The Production Manager is accountable for implementing and ensuring compliance with this SOP. The QC team is responsible for inspecting the packaging process and taking corrective actions if discrepancies are identified.
5. Procedure
5.1 Packaging Material Segregation
- Ensure that all packaging materials are clearly labeled with the correct batch numbers and product identifiers (Annexure-1).
- Store different packaging materials (labels, boxes, blister packs) in clearly defined, segregated areas to prevent accidental mix-ups (Annexure-2).
- Label storage areas for each material with batch numbers and expiration dates to ensure proper stock rotation and to prevent materials from being used out of order (Annexure-3).
5.2 Proper Labeling and Identification
- Ensure that all packaging materials are labeled with the correct product details, including batch number, expiry date, and product type (Annexure-4).
- Verify the accuracy of labels before placing them on packaging materials and ensure that labels are clearly visible and properly attached (Annexure-5).
- Use automated or manual systems to track product labeling and ensure that no incorrect labeling occurs during the packaging process (Annexure-6).
5.3 Packaging Process Monitoring
- During packaging, monitor the packaging process at each stage to ensure that the correct product and packaging materials are used (Annexure-7).
- Perform random sampling of packaged products to verify the correctness of the packaging and labeling (Annexure-8).
- If a mix-up is detected, stop the process immediately, isolate the affected batch, and notify the Production Manager and QC team (Annexure-9).
5.4 Packaging Area Cleanliness and Organization
- Maintain cleanliness in the packaging areas to prevent contamination or mix-ups of products and packaging materials (Annexure-10).
- Ensure that the packaging workstations are properly organized with designated areas for materials, tools, and products to avoid confusion during packaging (Annexure-11).
5.5 Handling and Storage of Finished Products
- After packaging, verify that the products are stored in the correct area, clearly labeled with batch numbers and expiry dates (Annexure-12).
- Ensure that finished products are segregated by batch number and product type to prevent cross-contamination or mix-ups (Annexure-13).
- Store packaged products in a secure area with limited access to prevent unauthorized handling or confusion (Annexure-14).
5.6 Documentation and Record-Keeping
- Document all steps in the packaging process, including material segregation, labeling, and packaging inspections (Annexure-15).
- Maintain records of any incidents involving packaging mix-ups, including the corrective actions taken (Annexure-16).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FIFO: First In, First Out
7. Documents
- Packaging Material Segregation Log (Annexure-1)
- Packaging Material Storage Log (Annexure-2)
- Material Labeling Verification Log (Annexure-3)
- Packaging Material Labeling Log (Annexure-4)
- Packaging Inspection Log (Annexure-5)
- Product Labeling Log (Annexure-6)
- Packaging Process Monitoring Log (Annexure-7)
- Sampling and Inspection Log (Annexure-8)
- Corrective Action Log (Annexure-9)
- Packaging Area Cleanliness Log (Annexure-10)
- Finished Product Storage Log (Annexure-11)
- Product Segregation Log (Annexure-12)
- Storage Area Log (Annexure-13)
- Packaging Process Documentation Log (Annexure-14)
- Packaging Mix-Up Incident Log (Annexure-15)
- Packaging Documentation Retention Log (Annexure-16)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
- ISO 9001 – Quality Management Systems
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 Segregation Log
| Material | Segregation Date | Operator | Storage Location |
|---|---|---|---|
| Blister Pack | 01/07/2026 | John Doe | Warehouse A, Shelf 2 |
Annexure-2: Packaging Material Storage Log
| Material | Storage Location | Storage Date | Quantity Stored |
|---|---|---|---|
| Blister Pack | Warehouse A, Shelf 2 | 01/07/2026 | 100,000 units |
Annexure-3: Material Labeling Verification Log
| Material | Labeling Date | Operator | Batch Number | Label Verification Status |
|---|---|---|---|---|
| Blister Pack | 01/07/2026 | John Doe | Batch 12345 | Verified |
Annexure-4: Packaging Material Labeling Log
| Material | Labeling Date | Operator | Batch Code | Label Status |
|---|---|---|---|---|
| Blister Pack | 01/07/2026 | Jane Smith | Batch 12345 | Completed |
Annexure-5: Packaging Inspection Log
| Material | Inspection Date | Inspector | Inspection Result | Comments |
|---|---|---|---|---|
| Blister Pack | 01/07/2026 | John Doe | Pass | No issues found |
Annexure-6: Product Labeling Log
| Product | Labeling Date | Batch Number | Operator |
|---|---|---|---|
| Blister Pack | 01/07/2026 | Batch 12345 | Jane Smith |
Annexure-7: Packaging Process Monitoring Log
| Material | Process Date | Operator | Action Taken | Outcome |
|---|---|---|---|---|
| Blister Pack | 02/07/2026 | John Doe | Corrected labeling error | Resolved, process continued |
Annexure-8: Sampling and Inspection Log
| Material | Sampling Date | Inspector | Sample Results |
|---|---|---|---|
| Blister Pack | 02/07/2026 | Jane Smith | Pass |
Annexure-9: Corrective Action Log
| Issue | Corrective Action Date | Action Taken | Responsible Person |
|---|---|---|---|
| Labeling Error | 02/07/2026 | Recalibrated the labeling machine | John Doe |
Annexure-10: Packaging Area Cleanliness Log
| Area | Cleaning Date | Operator | Cleaning Status |
|---|---|---|---|
| Packaging Station 1 | 01/07/2026 | Jane Smith | Cleaned and sanitized |
Annexure-11: Finished Product Storage Log
| Material | Storage Date | Location | Quantity Stored | Batch Code |
|---|---|---|---|---|
| Blister Pack | 02/07/2026 | Storage A, Shelf 5 | 50,000 units | Batch 12345 |
Annexure-12: Product Segregation Log
| Material | Segregation Date | Operator | Segregation Action |
|---|---|---|---|
| Blister Pack | 02/07/2026 | John Doe | Separated by batch number |
Annexure-13: Storage Area Log
| Material | Storage Area | Storage Date | Quantity Stored |
|---|---|---|---|
| Blister Pack | Storage Area A | 02/07/2026 | 50,000 units |
Annexure-14: Packaging Process Documentation Log
| Material | Document Type | Document Reference Number | Document Date |
|---|---|---|---|
| Blister Pack | Packaging Log | PKG-12345 | 02/07/2026 |
Annexure-15: Packaging Mix-Up Incident Log
| Incident Date | Material | Incident Type | Corrective Action | Reported By |
|---|---|---|---|---|
| 02/07/2026 | Blister Pack | Label mix-up | Replaced incorrect labels | John Doe |
Annexure-16: Packaging Documentation Retention Log
| Document Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Packaging Process Log | 5 years | Jane Smith | Storage A, Shelf 2 |
17. 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 |
| 01/07/2025 | 2.0 | Updated documentation retention and corrective action procedures | Process optimization | QA Head |