Standard Operating Procedure for Packaging of Chewable and Dispersible Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/249/2025 |
| Supersedes | SOP/TAB/249/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/07/2026 |
| Effective Date | 06/07/2026 |
| Review Date | 01/07/2027 |
1. Purpose
The purpose of this SOP is to define the procedure for packaging chewable and dispersible tablets to ensure that they are correctly and securely packaged, preserving their quality, stability, and safety until they reach the consumer. The SOP aims to ensure compliance with GMP and regulatory standards.
2. Scope
This SOP applies to the packaging of all chewable and dispersible tablets manufactured at the site. It includes the procedures for packing tablets into blister packs, bottles, or other suitable packaging, ensuring compliance with the required quality standards and regulatory guidelines.
3. Responsibilities
- Packaging Operators: Responsible for the correct operation of packaging machines, application of labels, and ensuring the correct packaging of chewable and dispersible tablets.
- Quality Control (QC): Responsible for overseeing the packaging process, verifying that all packaging operations are performed correctly, and ensuring compliance with quality standards.
- Production Manager: Ensures that the packaging process is conducted according to the SOP and takes corrective action if any deviations or issues arise during the packaging process.
4. Accountability
The Production Manager is accountable for ensuring that the packaging of chewable and dispersible tablets follows the SOP. The QC Manager is responsible for confirming the quality of the final packaged products.
5. Procedure
5.1 Preparation for Packaging
- Ensure that the chewable and dispersible tablets are ready for packaging and have undergone all necessary quality checks, including hardness, disintegration, and weight uniformity testing (Annexure-1).
- Verify that the correct packaging materials are available for the batch, including blister packs, bottles, or other containers, and that they comply with the approved specifications (Annexure-2).
- Ensure that the labeling and secondary packaging materials (e.g., cartons, leaflets) are available and match the approved design (Annexure-3).
5.2 Packaging Process
- Start the packaging process by setting up the packaging machine according to the batch specifications (Annexure-4).
- For blister packaging, ensure that the blister cavities are properly aligned and filled with the correct number of tablets (Annexure-5).
- For bottle packaging, ensure that the correct quantity of tablets is filled into each bottle (Annexure-6).
- Ensure that the labeling machine applies the correct labels on each package, including the product name, batch number, expiry date, and any other regulatory information (Annexure-7).
- Verify that all tamper-evident seals and closure systems are applied correctly to maintain product integrity (Annexure-8).
- If any issues such as misalignment, broken seals, or incorrect labeling are detected, stop the process and rectify the issue before continuing (Annexure-9).
5.3 Quality Checks During Packaging
- QC personnel must inspect a sample of each batch during packaging to ensure that the labeling, sealing, and packaging materials are compliant with specifications (Annexure-10).
- Check that the packaging is properly sealed and there is no visible damage (Annexure-11).
- If any non-compliance is found, the batch should be quarantined until the issue is resolved (Annexure-12).
5.4 Post-Packaging Inspections
- Once packaging is completed, inspect the finished product for any packaging defects, such as damaged blister packs, incorrect labels, or improperly sealed bottles (Annexure-13).
- Conduct a final weight check and verify that all regulatory information is included (Annexure-14).
- Prepare the packaged tablets for storage or distribution, following the appropriate procedures for finished goods handling (Annexure-15).
5.5 Documentation and Record-Keeping
- Maintain a detailed log of the packaging process, including batch number, packaging date, and the quantity of tablets packed (Annexure-16).
- Ensure that all packaging records are retained for a minimum of two years or as required by regulatory authorities (Annexure-17).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
7. Documents
- Batch Record Log (Annexure-1)
- Packaging Material Specifications (Annexure-2)
- Labeling Specifications (Annexure-3)
- Packaging Machine Setup Log (Annexure-4)
- Blister Pack Inspection Log (Annexure-5)
- Bottle Packaging Inspection Log (Annexure-6)
- Label Application Log (Annexure-7)
- Sealing and Tamper-Evident Seal Check Log (Annexure-8)
- Packaging Defect Report (Annexure-9)
- Post-Packaging Inspection Log (Annexure-10)
- Finished Goods Inspection Log (Annexure-11)
- Final Weight Check Log (Annexure-12)
- Finished Goods Storage Log (Annexure-13)
- Packaging Process Log (Annexure-14)
- Finished Goods Documentation Log (Annexure-15)
- Packaging Records Retention Log (Annexure-16)
- Packaging Compliance Records (Annexure-17)
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: Batch Record Log
| Batch Number | Batch Size | Packaging Date | Operator |
|---|---|---|---|
| Batch 12345 | 1000 tablets | 01/07/2026 | John Doe |
Annexure-2: Packaging Material Specifications
| Material Type | Specification | Quantity |
|---|---|---|
| Blister Pack | 3×5, PVC | 1000 units |
Annexure-3: Labeling Specifications
| Label Type | Font Size | Text Color | Material |
|---|---|---|---|
| Primary Label | 12 pt | Black | Gloss Paper |
| Secondary Label | 10 pt | Blue | Matte Paper |
Annexure-4: Packaging Machine Setup Log
| Machine ID | Setup Date | Operator | Setup Completed |
|---|---|---|---|
| Machine 01 | 01/07/2026 | John Doe | Yes |
| Machine 02 | 01/07/2026 | Jane Smith | Yes |
Annexure-5: Blister Pack Inspection Log
| Batch Number | Inspection Date | Inspector | Comments |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | Jane Smith | Compliant – No issues found |
| Batch 12346 | 02/07/2026 | John Doe | Compliant – No issues found |
Annexure-6: Bottle Packaging Inspection Log
| Batch Number | Inspection Date | Inspector | Comments |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | Jane Smith | Compliant – No issues found |
| Batch 12346 | 02/07/2026 | John Doe | Compliant – No issues found |
Annexure-7: Label Application Log
| Batch Number | Label Application Date | Operator | Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Completed |
| Batch 12346 | 02/07/2026 | Jane Smith | Completed |
Annexure-8: Sealing and Tamper-Evident Seal Check Log
| Batch Number | Seal Inspection Date | Inspector | Seal Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Pass |
| Batch 12346 | 02/07/2026 | Jane Smith | Pass |
Annexure-9: Packaging Defect Report
| Batch Number | Defect Description | Corrective Action Taken | Reported By |
|---|---|---|---|
| Batch 12345 | Incorrect label applied | Reapplied the correct label | John Doe |
| Batch 12346 | Damaged packaging | Repackaged and checked | Jane Smith |
Annexure-10: Post-Packaging Inspection Log
| Batch Number | Inspection Date | Inspector | Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Pass |
| Batch 12346 | 02/07/2026 | Jane Smith | Pass |
Annexure-11: Finished Goods Inspection Log
| Batch Number | Inspection Date | Inspector | Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Pass |
| Batch 12346 | 02/07/2026 | Jane Smith | Pass |
Annexure-12: Final Weight Check Log
| Batch Number | Check Date | Weight Range | Operator |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | Within specification | John Doe |
Annexure-13: Finished Goods Storage Log
| Batch Number | Storage Date | Storage Location | Storage Condition |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | Storage Area A | Room Temperature, Dry |
| Batch 12346 | 02/07/2026 | Storage Area B | Refrigerated |
Annexure-14: Packaging Process Log
| Batch Number | Process Start Date | Operator | Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Completed |
| Batch 12346 | 02/07/2026 | Jane Smith | Completed |
Annexure-15: Finished Goods Documentation Log
| Document Type | Document Reference Number | Document Date |
|---|---|---|
| Packaging Record | PR-12345 | 01/07/2026 |
Annexure-16: Packaging Records Retention Log
| Material Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Blister Packs | 5 years | John Doe | Storage Area A |
Annexure-17: Packaging Compliance Records
| Batch Number | Compliance Date | Compliance Status | Verified By |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | Compliant | Jane Smith |
18. 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 |
| 01/07/2026 | 2.0 | Updated packaging procedure with new batch documentation logs and compliance records | Process optimization and updated regulatory requirements | QA Head |