SOP Title: Destruction of Residues and Line Rejects
- Objective:
To lay down procedure for destruction of residues generated during production activities.
- Scope:
This procedure is applicable to the destruction of residues and line rejects generated during various stages of manufacturing and packing in the site.
- Responsibility:
Production Department: To collect the in-process rejects in a suitable container, destroy as per procedure, label and transfer to the scrap yard or soak pit as applicable.
Housekeeping Personnel: To collect the waste or rejects from the production department and transfer to the scrap yard or soak pit as instructed.
QA Department: To ensure that the procedure is followed properly and to take decision for destruction, if the material quantity for destruction is more.
- Accountability:
Head QA/ Plant Head
- Procedure:
- Definitions:
Residues and Rejects: Includes raw, in-process and packing materials which are generated as rejects, scrap, leftover on the process equipment, or used for in-process checks during production of products and need specific control to prevent risk of reuse or safety to the health and environment.
Production Associate: Officer/Executive of or any personnel Production Department trained to perform duties as per this SOP.
QA Associate: Officer/Executive of or any personnel QA Department trained to perform duties as per this SOP.
- Procedure:
| 5.2.1 | Safety | |
| 5.2.1.1 | Destruction shall be done only after reconciliation of material and respective records completed. | |
| 5.2.1.2 | All destruction shall be done in the presence of Production and QA person. | |
| 5.2.1.3 | All rejects shall be properly labelled checked and recorded in BMR /BPR. | |
| 5.2.2 | General | |
| 5.2.2.1 | Raw materials spilled on the floor shall be destroyed by dissolving it in water & then putting the same in the soak pit if the quantity is less. | |
| 5.2.2.2 | Tablets from rejected strips / blisters / shall be removed before destruction. | |
| 5.2.2.3 | The reject / balance overprinted foil at the end of the batch shall be shredded and transferred to given for scrap yard. | |
| 5.2.2.4 | Ensure that the tablets / powder / granules to be rejected are not discarded by putting in the dustbin / waste basket. | |
| 5.2.3 | Destruction of Powder / Granules / Tablets / Capsule/Ointments | |
| 5.2.3.1 | Balance powder / granules remaining in the hopper at the end of the compression of the batch. Quantity not exceeding approximately 0.5 kg / batch.
Tablets brought out from the compression cubicle for checking individual weight variation, hardness, friability, etc. Defective tablets removed from rejected strips / blisters for improper sealing, empty pockets, spilled on floor or other defects. Destroy the residues or balance material mentioned above as per the relevant procedure given below: |
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| 5.2.3.2 | A suitable container labelled as “REJECTED” is kept in respective cubicles for destruction of in process samples. | |
| 5.2.3.3 | Collect the rejected granules / tablets in a suitable container. Add water to the container with stirring. Ensure that slurry is formed. | |
| 5.2.3.4 | Rejected capsules shall be opened to separate the powder & then dissolved in water. Destroy the resultant slurry by putting into the soak pit.
Note: If the quantity of rejects is increased due to any incident then the destruction/disposal decision shall be taken by QA Head and its disposal shall be handled as per respective SOP. |
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| 5.2.3.5 | Record the quantity of materials / tablets / capsules destroyed and operation in the respective BMR. | |
| 5.2.4. | Destruction of over printed Foil / Cartons / Labels | |
| 5.2.4.1 | Following are the materials which shall be destroyed:
Balance overprinted cartons / labels / foil / shippers etc after completion and reconciliation of the batch. Rejected cartons / labels / foil / shippers etc. |
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| 5.2.4.2 | Tear the rejected overprinted cartons labels shippers etc. into 2-4 pieces.
Shred the overprinted foil / rejected printed foil by passing through the shredder. Tear the torn overprinted cartons labels, foil, shippers etc. Record the quantity and operation in the respective BMR / BPR. |
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- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QAD | Quality Assurance Department |
| BMR | Batch Manufacturing Record |
| BPR | Batch Packing Record |
*Note – Ready to use SOP available in “DOWNLOAD” Section.