Receipt of Excess RM/PM from Production
1.0 Objective
To lay down a procedure for receipt of excess RM/PM from production.
2.0 Scope
This Standard Operating Procedure is applicable for receipt of excess RM/PM from production to be followed at formulation
plants of abc company.
3.0 Responsibility
3.1 Officer/Executive warehouse shall be responsible for the receipt of excess RM/PM from production.
3.2 Head Warehouse is 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 etc.
API : Active pharmaceutical ingredients
No : Number
i.e. : That is
RM : Raw material
PM : Packaging material
WH : Warehouse
QA : Quality Assurance
5.0 Procedure
5.1 No excess of raw materials (i.e. API, Excipients, Solvents, Colors, and Flavours etc.) return from Production
shall be received by Warehouse.
5.2 Excess/un-used primary packing material and secondary packing material including primary printed
material and secondary printed material shall be returned back to warehouse department.
5.3 The material shall be returned to Warehouse only in case of change in production schedule and any excess
quantity of packing material after finishing the packing of finished goods batch.
5.4 The material shall be received at warehouse by way of material return note.
5.5 Warehouse personnel shall count/ weigh each item returned by production department and shall check
the packet/container affix with the material status label “Material Return Note” indicating following information.
5.5.1 Name of the Product
5.5.2 Batch No /date
5.5.3 Item code
5.5.4 Material Description
5.5.5 A.R. No.
5.5.6 Quantity
5.6 Production personnel shall submit the ‘Material Returned Note’ in duplicate and get it signed by IPQA personnel.
The first copy shall be submitted to Warehouse Department along with the material, second copy shall be attached in BPCR.
5.7 Warehouse personnel shall verify the quantity as per the Material Return Note (MRN) and shall make the entry
in Master Resources Planning.
5.8 Warehouse personnel shall take charge of the returned packaging material & return the duplicate copy of material
return note (MRN) duly signed.
5.9 Warehouse personnel shall arrange for the storage of excess packaging material in their respective racks.
6.0 Forms and Records
6.1 None
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