procedure for handling of rejected 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
| Revision Number | Details For Change | Reason for Revision | 
| 00 | New SOP | NA | 
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test sop for Analytical Method Transfer Protocol for hold time study of sterile garments sop for swab sampling for validation of clean surfaces cleaning validation maco and noel calculation formula sop for performance qualification for analyst Sop for Validation report for disinfectant efficacy Sop for Method validation report for bacterial endotoxin test Sop for method validation microbiology sterility testing sop for validation report for preservative efficacy test sop for Protocol cum report for efficacy qualification of uv light sop for validation protocol for uv light efficacy of dpb & laf sop for cleaning validation protocol tablet manufacturing equipment 
 
 
 
 sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules sop for Validation for cleaning procedure liquid injection sop for Validation for cleaning procedure dry powder injection Preparation Approval Control and Distribution of Master Formula Records calibration policy for equipment and instruments evaluation Sampling of Raw Materials questionnaire training evaluation questionnaire sop for approval of Contract Parties sop for Operation and Cleaning of Purified Water Generation System sop for Storage of Standard Weights sop for Dispensing of Raw Material Receipt of Excess RM/PM from Production sop for Dispatches of Finished Goods Cleaning of Dispensing and Sampling Area procedure for cleaning of dispensing tools Cleaning and Operation of Reverse Laminar Air Flow Handling of Open-Damaged Containers in Warehouse sop for Discard of Scrap From Warehouse Cleaning and Operation of Reverse Laminar Air Flow sop for Cleaning of High Racks sop for Issuance of Excess RM/PM to Production sop for Cleaning of MS Shutter procedure for handling of rejected materials