Standard Operating Procedure for Handling Non-Conforming Products During Manufacturing
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/218/2025 |
| Supersedes | SOP/TAB/218/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
This SOP defines the procedures for identifying, handling, and resolving non-conforming products during the tablet manufacturing process. Its goal is to ensure that non-conforming products are properly managed to prevent their distribution and to improve overall product quality.
2. Scope
This SOP applies to all non-conforming products detected during tablet manufacturing, including raw materials, intermediates, and finished tablets. It covers all activities from identification, segregation, investigation, corrective actions, and documentation.
3. Responsibilities
- Production Manager: Responsible for identifying non-conforming products, ensuring their proper segregation, and reporting them to the Quality Assurance (QA) team.
- Quality Control (QC) Team: Responsible for evaluating the non-conforming products, conducting investigations, and providing recommendations for corrective actions.
- Quality Assurance (QA) Manager: Responsible for overseeing the resolution of non-conformances, reviewing investigation reports, and ensuring compliance with regulatory requirements.
- Regulatory Affairs Team: Ensures that non-conforming products are handled according to regulatory guidelines, especially when deviations could affect product compliance or safety.
4. Accountability
The QA Manager is accountable for ensuring that the non-conforming products are properly handled, investigated, and resolved according to this SOP. The Production Manager and QC Team are responsible for identifying, segregating, and reporting non-conformances.
5. Procedure
5.1 Identification and Segregation of Non-Conforming Products
- Identify non-conforming products through in-process inspections, QC testing, or visual examination during manufacturing (e.g., tablets failing hardness or disintegration testing).
- Immediately segregate non-conforming products from conforming products to prevent cross-contamination or accidental release.
- Label the non-conforming products clearly with a “Non-Conforming Product” label and place them in a designated quarantine area.
- Document the details of the non-conformance, including the batch number, product name, and nature of the non-conformance (Annexure-1).
5.2 Investigation of Non-Conformance
- The QC Team investigates the root cause of the non-conformance by reviewing batch records, conducting product testing, and analyzing the manufacturing process (Annexure-2).
- Use appropriate investigative techniques such as Root Cause Analysis (RCA) to identify the underlying cause of the non-conformance (Annexure-3).
- Document all findings from the investigation, including potential causes, impacts, and corrective action recommendations (Annexure-4).
5.3 Corrective Actions
- Develop corrective actions based on the investigation findings to address the root cause and prevent recurrence of the non-conformance (Annexure-5).
- Implement corrective actions as soon as possible and document all actions taken (Annexure-6).
- Verify the effectiveness of corrective actions by conducting follow-up inspections and testing of products produced after implementation (Annexure-7).
5.4 Reprocessing or Disposition of Non-Conforming Products
- If a non-conforming product can be reprocessed or reworked to meet quality specifications, provide detailed instructions on the steps to follow (e.g., re-blending, re-compressing, or re-coating) (Annexure-8).
- If the non-conforming product cannot be reprocessed or reworked, it must be properly disposed of according to the company’s waste disposal procedures (Annexure-9).
- Ensure that all reprocessed or disposed products are documented appropriately, with proper tracking and accountability (Annexure-10).
5.5 Documentation and Record Keeping
- Ensure that all records related to non-conforming products, investigations, corrective actions, and reprocessing or disposal are documented and securely stored (Annexure-11).
- Retain all records for a minimum of 5 years or as required by applicable regulations.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- CAPA: Corrective and Preventive Action
7. Documents
- Non-Conformance Report (Annexure-1)
- Investigation Report (Annexure-2)
- Root Cause Analysis Report (Annexure-3)
- Corrective Action Plan (Annexure-4)
- Corrective Action Implementation Record (Annexure-5)
- Reprocessing Instructions (Annexure-6)
- Disposal Records (Annexure-7)
- Reprocessing and Disposal Documentation (Annexure-8)
- Non-Conformance Documentation (Annexure-9)
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: Non-Conformance Report
| Non-Conformance ID | Description | Batch Number | Action Taken |
|---|---|---|---|
| NC001 | Potency Out of Specification | Batch123 | Recalibrated equipment and retested |
Annexure-2: Investigation Report
| Investigation ID | Findings | Corrective Action |
|---|---|---|
| INV001 | Improper calibration of equipment | Recalibrate equipment and perform routine checks |
Annexure-3: Root Cause Analysis Report
| Cause ID | Root Cause Description | Corrective Action |
|---|---|---|
| RCA001 | Inconsistent calibration of tablet hardness tester | Establish routine calibration schedule |
Annexure-4: Corrective Action Plan
| Action ID | Action Description | Completion Date |
|---|---|---|
| CAP001 | Recalibrate equipment | 06/03/2026 |
Annexure-5: Corrective Action Implementation Record
| Action ID | Action Implemented By | Result |
|---|---|---|
| CAP001 | Jane Smith | Successfully recalibrated equipment |
Annexure-6: Reprocessing Instructions
| Batch Number | Reprocessing Instructions | Completion Date |
|---|---|---|
| Batch123 | Re-blend and compress | 06/03/2026 |
Annexure-7: Disposal Records
| Batch Number | Disposal Method | Disposal Date |
|---|---|---|
| Batch123 | Incineration | 06/03/2026 |
Annexure-8: Reprocessing and Disposal Documentation
| Batch Number | Action Taken | Completion Date |
|---|---|---|
| Batch123 | Reprocessing completed | 06/03/2026 |
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 | Added documentation and tracking requirements | Annual review | QA Head |