Standard Operating Procedure for Storage and Handling of Rejected Materials
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/219/2025 |
| Supersedes | SOP/TAB/219/2022 |
| 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 the proper storage and handling of rejected materials during tablet manufacturing. Its goal is to ensure rejected materials are clearly segregated, handled safely, and disposed of according to regulatory requirements to maintain product quality and safety.
2. Scope
This SOP applies to all rejected materials in tablet manufacturing, including raw materials, intermediates, and finished products that do not meet specifications or quality standards.
3. Responsibilities
- Production Manager: Responsible for ensuring rejected materials are appropriately identified, segregated, and documented. Also ensures that rejected materials are stored safely.
- Quality Assurance (QA) Manager: Responsible for overseeing the handling and storage of rejected materials, ensuring compliance with regulatory standards and internal procedures.
- Quality Control (QC) Team: Responsible for performing tests to confirm non-conformance of materials and reporting to the QA department for further handling.
- Warehouse Team: Responsible for storing rejected materials in designated areas, ensuring proper labeling, and controlling access to these materials.
4. Accountability
The QA Manager is accountable for ensuring that all rejected materials are handled, stored, and disposed of properly according to this SOP. The Production, QC, and Warehouse teams are responsible for following this procedure in their respective areas.
5. Procedure
5.1 Identification of Rejected Materials
- Identify rejected materials through inspection, testing, or by feedback from the manufacturing process (e.g., failed dissolution, incorrect labeling, damaged packaging).
- Upon identification, immediately label the rejected materials as “Rejected” to avoid confusion with conforming products.
- Document the batch number, product name, type of rejection, and any relevant details (e.g., reason for rejection) in the Non-Conformance Report (Annexure-1).
5.2 Segregation of Rejected Materials
- Segregate rejected materials from conforming products immediately to prevent any accidental mix-up.
- Store rejected materials in a designated quarantine area that is clearly marked as “Rejected Materials.”
- Ensure that the storage area is secure, with restricted access to authorized personnel only.
5.3 Handling and Transport of Rejected Materials
- Handle rejected materials with care to prevent contamination or damage. Use appropriate protective equipment (e.g., gloves, masks, etc.) as necessary.
- If rejected materials need to be transported for further testing, reprocessing, or disposal, ensure they are securely sealed and properly labeled during transit.
- Ensure that rejected materials are handled in a manner that complies with safety and environmental standards.
5.4 Disposal of Rejected Materials
- If rejected materials cannot be reprocessed, reworked, or reused, dispose of them following company’s waste disposal procedures (Annexure-2).
- Ensure that rejected materials are disposed of in an environmentally responsible manner and in accordance with applicable laws and regulations.
- Document all disposal activities, including the quantity, batch numbers, and disposal method used (Annexure-3).
5.5 Record Keeping and Documentation
- Maintain detailed records of all rejected materials, including the reason for rejection, the actions taken, and the final disposition (Annexure-4).
- Store all rejection and disposal documentation for a minimum of 5 years, or as required by applicable regulations, in a secure location.
5.6 Review and Analysis
- Review records of rejected materials periodically to identify any trends or recurring issues that may indicate a need for corrective or preventive actions.
- Analyze the root causes of frequent rejections and implement corrective actions as necessary (Annexure-5).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- GMP: Good Manufacturing Practice
- CAPA: Corrective and Preventive Action
7. Documents
- Non-Conformance Report (Annexure-1)
- Rejected Materials Disposal Record (Annexure-2)
- Rejected Materials Documentation (Annexure-3)
- Rejection and Handling Records (Annexure-4)
- Root Cause Analysis for Rejected Materials (Annexure-5)
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 | Tablet weight out of specification | Batch123 | Rework and retest |
Annexure-2: Rejected Materials Disposal Record
| Batch Number | Reason for Rejection | Disposal Method | Disposal Date |
|---|---|---|---|
| Batch123 | Out-of-specification weight | Incineration | 06/03/2026 |
Annexure-3: Rejected Materials Documentation
| Material | Batch Number | Reason for Rejection | Action Taken |
|---|---|---|---|
| Tablet ABC | Batch123 | Out-of-specification dissolution rate | Material segregated and sent for disposal |
Annexure-4: Rejection and Handling Records
| Batch Number | Rejection Date | Handled By | Final Disposition |
|---|---|---|---|
| Batch123 | 05/03/2026 | John Doe | Disposed of |
Annexure-5: Root Cause Analysis for Rejected Materials
| Issue | Root Cause | Corrective Action |
|---|---|---|
| Tablet weight out of specification | Incorrect calibration of tablet press | Recalibrate tablet press and perform regular checks |
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 |
| 01/02/2025 | 2.0 | Updated handling and disposal procedures | Annual review | QA Head |