Handling of Rejected Raw & Packaging Materials

1.0 Objective
To lay down a procedure for handling of rejected materials.
2.0 Scope
This Standard Operating Procedure is applicable for handling of rejected materials to be followed

at formulation plants of ABC Company.
3.0 Responsibility
3.1 Officer / Executive warehouse shall be responsible for handling of rejected materials.
3.2 Head Warehouse shall be responsible for implementation of this SOP.
3.3 Head QA or his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
No. : Number
WH : Warehouse
HOD : Head of Department
RGP : Retumable Gate Pass
NRGP : Non Retumable Gate Pass
QA : Quality Assurance
QC : Quality Control
5.0 Procedure
5.1 Raw Material
5.1.1 QC shall intimate warehouse department by providing rejected material labels and affix it on the material.
5.1.2 After affixing the rejected material label, the rejected material shall be transferred from

under test room to rejected material room. The room shall be kept under lock & key.
5.1.3 The list of the rejected material shall be displayed in the rejected material room as per Annexure-1.
5.1.4 QA shall send the “Rejection Report” to Warehouse and Purchase department.
5.1.5 Warehouse personnel shall inform the purchase department to rejection details.
5.1.6 Purchase Department shall send the material return intimation to Warehouse, allowing

warehouse either return back the material or destroy the material.
5.1.7 Warehouse department shall re-book the material to the supplier’s destination with in 15 days

from the receipt of material return intimation from purchase department by raising Non-Returnable gate pass.
5.1.8 In case of destruction of the material, Warehouse shall fill the “Destruction Note” and take

the sign of QA Manager, Plant Head and QA Head and destroy as per the suggested mode

of destruction in presence of QA personnel and Security Personnel as per respective QA SOP No.:
5.2 Primary, Secondary and Tertiary Packaging Material
5.2.1 After receiving the intimation from QA department, the rejected material shall be

transferred to rejected material room.
5.2.2 In case of printed packaging material, warehouse shall fill the “Destruction Note” and take

the sign of QA Manager, Plant Head and QA Head and destroy as per the suggested mode

of destruction in presence of QA personnel and Security Personnel.
5.2.3 In case the un-printed packaging material needs to be rectified, it shall be sent to the vendor for necessary rectification on RGP and record shall be maintained.
6.0 Forms and Records
6.1 Rejected Material List – Annexure -1
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Warehouse Department.
8.0 History