SOP Title: Product Reprocessing
- Objective:
This procedure demonstrates the details of reprocessing/reworking of manufactured /packed batches of products that conform to the required quality.
- Scope:
Applicable to only those products, where reprocessing/packaging rework is required.
- Responsibility:
Head Logistics: Responsible for receipt and transfer of goods to warehouse
Head Warehouse: Responsible to transfer of goods to production department with transfer note for reprocessing.
Head Production: Responsible for reprocessing/reworking
Head QA: To approve reprocessing/rework
- Accountability:
Head QA / Head Production
- Procedure:
- Definitions:
- Rework/Reprocessing: Rework / reprocessing is the execution of an operation in existing batch due to minor packaging variation.
- QA Associate: Officer, Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Production Associate: Officer, Executive of Production Department or any personnel trained to perform duties as per this SOP.
- QC Associate: Analyst, Supervisor, Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
- Warehouse Associate: Officer, Executive of Warehouse Department or any personnel trained to perform duties as per this SOP.
- Procedure:
| 5.2.1 | Rework or Reprocessing of the product may be carried out for various reasons such as wrong Batch No. & Expiry Date, Improper or incorrect labelling, Defects in packaging components, additional labelling requirement. | |
| 5.2.2 | The batches for rework will be returned to Production Department by the Warehouse Department along with Transfer Note. | |
| 5.2.3 | The batch will be shifted to the manufacturing area under appropriate controlled conditions. | |
| 5.2.4 | Prior to start of the rework to ensure that working conditions are maintained and approval from contract giver is obtained for rework. | |
| 5.2.5 | Hand over the old BPR, along with the new BPR to the Production Head. | |
| 5.2.6 | QA shall draw bulk sample and send request to QC Department for analysis as per “Test Request for Bulk Product”. | |
| 5.2.7 | The QC Department shall examine the Bulk with relevant product specification. | |
| 5.2.8 | After completion of analysis and approval by QC Department the rework will be carried out as per relevant BPR. | |
| 5.2.9 | On completion of the rework a Finished Product sample shall be drawn for analysis. | |
| 5.2.10 | The Batch Packaging Record shall be clearly marked as rework / reprocessing along with the comments for reason of rework. | |
| 5.2.11 | The rework Batch Packaging Record and initial Batch Packaging Record shall be placed together. | |
| 5.2.12 | Reworked /reprocessed batches shall be kept for stability study if requires. | |
| 5.2.13 | Finally reworked batch shall be released by the QA Department. |
- Abbreviation:
| Abbreviation | Expansion |
| BPR | Batch Packing Records |
| QA | Quality Assurance |
| QC | Quality Control |
| No. | Number |
*Note – Ready to use SOP available in “DOWNLOAD” Section.