1.0 Purpose
1.1 To provide a procedure for storage, handling and return/disposal
of rejected raw and packing materials.
2.0 Scope
2.1 This SOP shall be applicable to all rejected raw and packing
materials at Warehouse of NAME Pharma Limited .
3.0
Responsibility
3.1 Warehouse Officer : To monitor and implementation of SOP.
3.2 Warehouse In-Charge : Review of system compliance.
3.3
Manager, QA :
Approval for Disposal and destruction.
4.0 Definition & Abbreviation
4.1 None
5.0 Materials & Equipment
5.1 None.
6.0
Precaution
/ Health and Safety Considerations
6.1 Ensure all the rejected materials are returned to vendor or disposed within 6 months from the Date of rejection, under advice to materials procurement department.
6.2 In the event of Insurance clearance to be obtained, all efforts will be made to expedite.
6.3
Ensure the door of Rejected material store shall always be locked and
Keys shall always be kept in the custody of Warehouse In-charge.
7.0 Procedure
7.1 Ensure all the rejected containers are labeled for rejection status.
7.2 Shift the Rejected Raw Materials to the dedicated “Rejected Raw Material Store” and Rejected Packing Materials to “Rejected Packing Materials Store. While shifting materials rejected at receipt due to damaged packaging, transfer the complete damaged pack into a suitable size Polyethylene bag, and secure the bag with a nylon rope / cable tie.
7.3 File the “Rejection Report” in “Rejected materials disposal” file.
7.4 Intimate the Purchase department, as per their instruction arrange for dispatch of rejected material back to vendor.
7.5 Prepare the Delivery Challan/Gate pass and put remark, “Rejected material returned”.
7.6 Take the signature of the supplier representative on the Delivery challan/Gate pass as a receipt of the rejected material.
7.7 Handover the Delivery challan/Gate pass to transporter, one copy to security, and file one copy along with rejection report in “Disposal Materials” file.
7.8 Rejected printed packing materials shall not be returned to the supplier as these materials shall be destroyed at the premises.
7.9 Make the entry on the bin card / stock register for the returned material.
7.10 If the “Rejection Report” is after retesting the material, the material is to be destroyed.
7.11 Inform quality assurance department for destruction, Schedule the date of destruction and destroy the material as per Quality assurance SOP for destruction.
7.12
Update the entries of destruction
in related stock registers and file Xerox copy of destruction report in Warehouse.
8.0 Reference Document
8.1 WHO GMP Guideline, trs-986, annex-2
8.2 In-house
9.0 Annexure
9.1 None
10.0 Revision History
|
Version No. |
Brief
Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
- |
11.0 Training
11.1 Training on this SOP is required for respective operators and Executives
of Warehouse
