Standard Operating Procedure for Weight Control During Strip Packing Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/243/2025 |
| Supersedes | SOP/TAB/243/2022 |
| 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 ensure that the weight of tablets in the strip packing process is accurately controlled to meet the specified weight range. This helps maintain product quality and compliance with regulatory standards.
2. Scope
This SOP applies to all strip packing operations for tablet products, specifically focusing on controlling the weight of tablets during the packing process. It includes procedures for checking, adjusting, and monitoring the weight of tablets during the strip packing process.
3. Responsibilities
- Packaging Operators: Responsible for ensuring the correct weight of tablets during the strip packing process and reporting any weight discrepancies immediately.
- Quality Control (QC) Inspectors: Conducts random inspections and checks to verify that the weight of tablets in strips meets the specified range.
- Production Manager: Ensures that the SOP is followed properly and that corrective actions are taken in case of discrepancies in tablet weight.
- Maintenance Personnel: Ensures that the strip packing machine is calibrated correctly and remains in
good working condition to prevent weight discrepancies.
4. Accountability
The Production Manager is accountable for ensuring that all operators adhere to this SOP and that the weight control process is implemented consistently. The QC department is responsible for monitoring and verifying tablet weight compliance.
5. Procedure
5.1 Calibration of Strip Packing Machine
- Before starting each production run, ensure that the strip packing machine is calibrated to meet the required weight specifications (Annexure-1).
- Verify that the weighing scale used for checking tablet weight is calibrated and verified as accurate (Annexure-2).
- Record the calibration date and any relevant details in the calibration log (Annexure-3).
5.2 Monitoring Tablet Weight During Packing
- During the strip packing process, monitor the weight of tablets at regular intervals using the calibrated weighing scale (Annexure-4).
- Take a representative sample of tablets every 15 minutes (or per production schedule) to ensure that the weight is within the specified range (Annexure-5).
- If any deviation from the target weight is observed, immediately stop the packing process and inform the Production Manager (Annexure-6).
- Adjust the packing machine settings as required to bring the weight back into the acceptable range (Annexure-7).
5.3 Corrective Action in Case of Weight Deviation
- When a weight deviation is identified, investigate the cause of the issue. Possible causes include machine malfunction, incorrect material feed, or packaging material inconsistencies (Annexure-8).
- Correct the issue immediately by adjusting the machine settings or replacing faulty parts (Annexure-9).
- Once the issue is resolved, resume the packing process, continuing to monitor the weight until stability is restored (Annexure-10).
5.4 Documentation and Record-Keeping
- Ensure all weight checks, adjustments, and corrective actions are documented in the relevant logs (Annexure-11).
- Maintain records of weight inspection results, including batch number, tablet type, date, and time of inspection (Annexure-12).
- All weight control documentation must be retained according to the company’s documentation retention policy (Annexure-13).
5.5 Regular Maintenance and Machine Checks
- Perform regular maintenance of the strip packing machine according to the manufacturer’s guidelines to prevent weight deviations caused by machine malfunction (Annexure-14).
- Inspect and clean the weighing system regularly to ensure accurate readings during the packing process (Annexure-15).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FIFO: First In, First Out
7. Documents
- Calibration Log (Annexure-1)
- Weighing Scale Calibration Log (Annexure-2)
- Calibration Report (Annexure-3)
- Tablet Weight Monitoring Log (Annexure-4)
- Tablet Weight Inspection Log (Annexure-5)
- Deviation Report (Annexure-6)
- Corrective Action Log (Annexure-7)
- Packaging Machine Maintenance Log (Annexure-8)
- Packaging Issue Report (Annexure-9)
- Packaging Process Log (Annexure-10)
- Weight Control Documentation (Annexure-11)
- Weight Inspection Records (Annexure-12)
- Documentation Retention Log (Annexure-13)
- Machine Maintenance Checklist (Annexure-14)
- Weighing System Inspection Log (Annexure-15)
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: Calibration Log
| Machine | Calibration Date | Operator | Calibration Results |
|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | John Doe | Pass |
Annexure-2: Weighing Scale Calibration Log
| Scale Type | Calibration Date | Operator | Scale Accuracy |
|---|---|---|---|
| Digital Scale | 01/07/2026 | Jane Smith | Within tolerance |
Annexure-3: Calibration Report
| Equipment | Calibration Date | Calibrated By | Calibration Result | Next Calibration Due |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | John Doe | Pass | 01/07/2027 |
Annexure-4: Tablet Weight Monitoring Log
| Material | Inspection Date | Operator | Tablet Weight (g) | Result | Corrective Action (if any) |
|---|---|---|---|---|---|
| Blister Pack | 02/07/2026 | John Doe | 0.250 | Pass | None |
| Blister Pack | 02/07/2026 | Jane Smith | 0.255 | Pass | None |
Annexure-5: Tablet Weight Inspection Log
| Batch Number | Inspection Date | Inspector | Weight Range | Inspection Result | Comments |
|---|---|---|---|---|---|
| Batch 12345 | 02/07/2026 | John Doe | 0.240g – 0.260g | Pass | No issues found |
| Batch 12345 | 02/07/2026 | Jane Smith | 0.240g – 0.260g | Pass | Uniform weight observed |
Annexure-6: Deviation Report
| Material | Deviation Date | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| Blister Pack | 02/07/2026 | Tablet weight out of range | Adjusted machine settings | John Doe |
| Blister Pack | 02/07/2026 | Tablet weight variance | Replaced faulty packaging material | Jane Smith |
Annexure-7: Corrective Action Log
| Issue | Corrective Action Date | Corrective Action Taken | Responsible Person |
|---|---|---|---|
| Tablet weight deviation | 02/07/2026 | Recalibrated the packing machine | John Doe |
Annexure-8: Packaging Machine Maintenance Log
| Machine | Maintenance Date | Maintenance Performed | Operator |
|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | Routine cleaning and calibration | Jane Smith |
Annexure-9: Packaging Issue Report
| Issue | Issue Reported Date | Resolution Date | Action Taken | Responsible Person |
|---|---|---|---|---|
| Tablet weight discrepancy | 02/07/2026 | 02/07/2026 | Adjusted machine settings | John Doe |
Annexure-10: Packaging Process Log
| Material | Process Date | Operator | Action Taken | Outcome |
|---|---|---|---|---|
| Blister Pack | 02/07/2026 | Jane Smith | Recalibrated weight control system | Weight control stabilized |
Annexure-11: Weight Control Documentation
| Batch | Inspection Date | Weight Range | Action Taken |
|---|---|---|---|
| Batch 12345 | 02/07/2026 | 0.240g – 0.260g | Machine recalibrated |
Annexure-12: Weight Inspection Records
| Material | Inspection Date | Inspector | Weight Range | Inspection Result |
|---|---|---|---|---|
| Blister Pack | 02/07/2026 | John Doe | 0.240g – 0.260g | Pass |
Annexure-13: Documentation Retention Log
| Document Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Weight Control Logs | 5 years | Jane Smith | Storage B, Shelf 3 |
Annexure-14: Machine Maintenance Checklist
| Machine | Maintenance Date | Maintenance Type | Maintenance Performed |
|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | Routine Inspection | Recalibrated machine, checked weight control settings |
Annexure-15: Weighing System Inspection Log
| Scale Type | Inspection Date | Inspector | Result |
|---|---|---|---|
| Digital Scale | 01/07/2026 | John Doe | Pass |
16. 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 weight monitoring procedures | Process optimization | QA Head |