Standard Operating Procedure for Managing Rework and Reprocessing of Tablet Batches
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/226/2025 |
| Supersedes | SOP/TAB/226/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
The purpose of this SOP is to define the procedure for managing rework and reprocessing of tablet batches. This ensures that any batch that does not meet specifications can be safely reprocessed or reworked, adhering to quality standards and regulatory requirements.
2. Scope
This SOP applies to all tablet batches that fail to meet in-process specifications, such as weight, hardness, or dissolution rate, and are designated for rework or reprocessing. It covers all tablet forms, including immediate release, sustained release, and chewable tablets.
3. Responsibilities
- QA Manager: Responsible for reviewing and approving the rework and reprocessing protocols, ensuring that reworked batches comply with all regulatory requirements.
- Production Team: Responsible for executing the rework and reprocessing procedures and ensuring that all batches meet the required specifications after rework.
- Process Engineering Team: Responsible for providing technical support for rework and reprocessing procedures, including process adjustments and troubleshooting.
- Regulatory Affairs Team: Ensures that the rework and reprocessing activities meet regulatory requirements and maintains proper documentation for inspections and audits.
4. Accountability
The QA Manager is accountable for ensuring that all rework and reprocessing activities are in compliance with GMP and regulatory standards. The Production and Process Engineering teams are responsible for carrying out the rework and reprocessing operations, while the QA team ensures that all processes are documented and meet quality standards.
5. Procedure
5.1 Identification of Batches for Rework or Reprocessing
- Upon identification of a non-conforming batch, the Production Supervisor shall notify the QA team for further assessment (Annexure-1).
- The QA team will review the batch documentation, including batch records and laboratory testing results, to determine the cause of the non-conformance (Annexure-2).
- If the issue is deemed reworkable or reprocessable, QA will assign a batch number for the reworked batch and proceed with the rework/reprocessing plan.
5.2 Rework Procedure
- The rework process involves correcting the non-conforming batch to meet the required specifications. For example, adjusting the tablet hardness or re-blending the batch to correct uniformity issues (Annexure-3).
- Document all rework activities, including the reason for rework, process adjustments, and any additional testing done (Annexure-4).
- Upon completion of rework, the batch must undergo re-testing to ensure that it meets the required specifications for quality, safety, and efficacy (Annexure-5).
- The reworked batch should be clearly labeled as “Reworked” and kept separate from standard batches during the final processing stages.
5.3 Reprocessing Procedure
- If a batch fails to meet specifications after initial testing, it may be subjected to reprocessing, which involves returning the batch to the production line for further processing steps, such as compression, coating, or drying (Annexure-6).
- During reprocessing, ensure that the batch is evaluated for any potential risks of contamination or quality issues that could impact the final product (Annexure-7).
- Monitor critical parameters (e.g., granulation, drying time, coating thickness) during reprocessing to ensure that all specifications are met (Annexure-8).
5.4 Documentation and Record Keeping
- All rework and reprocessing activities must be thoroughly documented, including the reason for rework/reprocessing, batch history, and any changes made to the process (Annexure-9).
- Document the testing results, corrective actions taken, and final batch status in the Rework and Reprocessing Log (Annexure-10).
- All records related to rework and reprocessing should be retained for a minimum of 5 years or as required by regulatory authorities.
5.5 Approval and Final Review
- After rework or reprocessing, the final batch should undergo a full review by the QA team to ensure compliance with specifications and regulatory requirements.
- Once the batch meets specifications, QA will approve the batch for further processing and packaging, and it will be released for distribution (Annexure-11).
- Any deviations during the rework or reprocessing process must be documented and investigated, and corrective actions must be implemented before final approval (Annexure-12).
5.6 Rework and Reprocessing Monitoring
- Regularly monitor rework and reprocessing activities to ensure that they are carried out in compliance with GMP and SOPs (Annexure-13).
- Perform periodic audits of reworked batches to identify any trends in non-conformances and implement corrective actions as necessary.
- Ensure that any reworked or reprocessed batch undergoes the same level of scrutiny and testing as a standard batch.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- OOS: Out of Specification
- R&D: Research and Development
7. Documents
- Rework and Reprocessing Log (Annexure-1)
- Batch History Documentation (Annexure-2)
- Rework Process Adjustment Log (Annexure-3)
- Rework Testing Log (Annexure-4)
- Reprocessing Documentation (Annexure-5)
- Reprocessing Parameters Monitoring Log (Annexure-6)
- Final Batch Approval Log (Annexure-7)
- Rework and Reprocessing Record (Annexure-8)
- Deviation and Corrective Action Log (Annexure-9)
- Rework and Reprocessing Review Log (Annexure-10)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- GMP Guidelines for Pharmaceutical Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Rework and Reprocessing Log
| Batch Number | Rework/Reprocessing Date | Reason for Rework | Actions Taken | Final Status |
|---|---|---|---|---|
| Batch123 | 01/03/2026 | Hardness out of specification | Re-blended and re-compressed | Pass |
Annexure-2: Batch History Documentation
| Batch Number | Initial Test Results | Initial Non-Conformance | Corrective Action Taken |
|---|---|---|---|
| Batch123 | Weight: 499 mg | Out of weight specification | Reblended and rechecked |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New process | QA Head |
| 01/02/2025 | 2.0 | Updated rework process to include further process adjustments | Updated process and compliance | QA Head |