SOP Title: Product Recovery
- Objective:
This procedure provides the details for the recovery of earlier batches of products that conform to the required quality by incorporation in subsequent batch.
- Scope:
Applicable to only those products where permitted in Master Formulation.
- Responsibility:
Production Head: To request test of additional recovery residue, addition of recovery, reconciliation and record the recovery in BMR/BPR.
QA Head: To approve recovery.
QC Head: To carry the relevant test and release the recovery residue.
- Accountability:
Head QA/ Head Production
- Procedure:
- Definitions:
- Recovery: Recovery is the introduction of all or part of previous batches of the required quality into a new batch at a defined stage of manufacture.
- Residue: Residues are the rejections collected at various stages of processing of a product.
- QA Associate: Officer, Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Production Associate: Officer, Supervisor, 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.
- Procedure:
| 5.2.1 | During the processing of a batch rejections may arise for various reasons such as chipping of tablets, improper locking of capsules, cut pockets in strip pack, less filled jars etc. The quantity of recoverable residue generated at various stages shall be recorded in the process history sheet of the BMR/BPR. | |
| 5.2.2 | The quantity of residue to be utilized in a subsequent batch shall be entered in the second part of BMR/BPR Register. | |
| Note:
a) The addition of residues to the subsequent batch shall be done not later than three months from the date of manufacture of the earliest batch. b) The quantity of the residue from earlier batch in the subsequent batch shall not exceed 10% of the next batch or as permitted according to Master Formulation. c) The residues generated from recovery added batches shall not be added to the subsequent batches. d) The expiry date of the batch shall not be changed after addition of recovery. |
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| 5.3 | Tablets (To be added to the subsequent batches): | |
| 5.3.1 | A “Test Request Form” shall be sent to the QC Department requesting them to examine, identify and approve the addition of recovery to the subsequent batch. The batch number, quantity of the recovery, Mfg. Date and Exp. Date shall be recorded on the “Test Request Form”. | |
| 5.3.2 | Examine the recovery with relevant product specification for critical test of assay, identification or any impurity profile (if any). | |
| 5.3.3 | After obtaining QC Approval, the recovery shall be processed as per steps mentioned in the relevant Batch Manufacturing Record and added at Granulation Stage. | |
| 5.4 | Capsules (to be added to the subsequent batches): | |
| 5.4.1 | Refer the points 5.3.1 and 5.3.2 | |
| 5.4.2 | After obtaining QC Approval, the recovery shall be processed as per steps mentioned in the BMR and added at Blending Stage. | |
| 5.4.3 | The batches containing recoveries shall be subjected to Stability Studies. | |
| 5.4.4 | The batches containing recoveries shall be mentioned specifically in APR. | |
| 5.4.5 | The batches containing recoveries shall be subjected to additional testing, if required before release. | |
| 5.4.6 | The process of adding recovery shall be validated, a Process Validation Protocol shall be generated simultaneously. | |
| 5.4.7 | QA Department shall fill the Format “Test Request For Stability” the batch of the product in which recovery added. | |
- Abbreviation:
| Abbreviation: | Expansion |
| BMR | Batch Manufacturing Records |
| BPR | Batch Packing Records |
| APR | Annual Product Review |
*Note – Ready to use SOP available in “DOWNLOAD” Section.