SOP of Receiving the raw materials and packaging materials
To lay down a procedure for receiving the raw materials and packaging materials.
This SOP is applicable for the receipt of Raw and Packing material to the warehouse of the formulation plant at (Pharmaceutical Company Name).
Raw Material and Packing Material warehouse personnel is responsible for the receipt of raw materials and packing materials.
The concerned department head shall be responsible for compliance and implementation of SOP.
Abbreviations and Definitions
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- RM: Raw Material
- PM: Packaging Material
- GRN: Goods Receipt Note
- MRN: Material Received a note
- A.R.No: Analytical Report Number
- P.O: Purchase Order
- INR: Indian Rupees
- CST: Commercial Sales Tax
- LST: Local Sales Tax
- DTC: Duplicate Transporters copy
- LOD: Loss on Drying
- L.R.No: Lorry Number
- Inv.No: Invoice Number
- UOM: Units of Mode
Security personnel shall receive and make entries in the ‘Security Register for Incoming RM/PM’ as per Annexure –I and shall stamp the back side of the Invoice / Delivery Chelan with the serial number, date, and signature.
The security personnel shall inform the concerned warehouse personnel regarding the receipt of material.
Warehouse personnel shall verify the following against the purchase order and delivery Chelan / invoice.
Name of material
Quantity of material
The material shall be unloaded from the vehicle under the supervision of warehouse personnel to material receipt area
The Warehouse personnel shall perform checking for received material in terms of physical appearance as per Annexure – X.
The received materials shall be stored on pallets.
In addition to above the following checks shall be performed
In case, the raw material and packaging material are found shortage after verification, Intimation shall be generated from the Officer or above-warehouse related to shortage of received material intimating to Head-Warehouse.
Head-Warehouse shall further forward the same to purchase department after due authorization.
Any discrepancy in terms of improper labeling, documentation and condition of material / container shall be intimated to the Head-Warehouse
If there is any abnormality in the consignment of RM/PM (Except printed packaging material, the same shall be sent back to the manufacturer/supplier, along with ‘Gate Pass Returnable / Non-Returnable’ as per Annexure – II detailing the reason for return.
The materials received in open condition shall not be accepted.
In case of printed packaging material, the material shall be destroyed in the presence of the manufacturer/supplier or prior information shall be forwarded to manufacturer / supplier in case of non-availability of manufacturer / supplier.
A partly damaged or fully damaged consignment during transit shall be received only after reviewing the extent of damage on material quality and quantity by Quality Control Department as per “Request to Quality control for Verification of Received Material” as per Annexure – III.
For damaged consignment, a damage certificate or any appropriate document shall be obtained from the transporter before receiving the material.
A copy of the document shall be sent to purchase department for settlement of claim, if applicable, from the insurance or supplier.
Clean and de-dust all the received material.
After cleaning, the material shall be shifted to Quarantine area and kept storage after verifying the required storage conditions as mentioned on the manufacturer label or as per in-house specification.
Ware house personnel shall prepare and affix Quarantine label to each container.
Officer or above-Warehouse shall inspect the consignment and prepare the Goods Received Note (GRN) as per Annexure – IV.
A request shall be forwarded to QC department i.e. “Test Request for Raw / Packaging Materials” as per Annexure – IX notifying the specification reference for sampling and testing of the received material along with GRN.
On receipt of Requisition and GRN from ware house, QC personal shall check the GRN and sample the Raw material and Packing material respectively.
On completion of received material analysis by QC, the Head-QC shall approve the received material in Test Request for Raw / Packaging Materials.
After approval by QC, first copy (White colored) of a GRN and a Test Request for Raw/packing material shall be retained with Ware house, second copy (pink colored) to QC and third copy forwarded (yellowish green) to Purchase department.
Ware house personal shall initiate MRN as per Annexure – XI.
The warehouse personnel shall enter the details in “Incoming Material Register for Raw material and Packing material as per Annexure – V and as per Annexure-VI correspondingly.
Subsequently the approved material issuance for manufacturing, reconciliation and exact stock (final stock) details shall be entered in “Stock Register of Raw Material” as per Annexure – VII and “Stock Register Packaging Material” as per Annexure – VIII for packaging material.
- Forms and Records
Security register for incoming RM/PM – Annexure I
Gate pass returnable / non-returnable – Annexure II
Request to QC department for verification of received material – Annexure III
Goods Received Note – Annexure IV
Incoming material register (Raw Material) – Annexure V
Incoming material register (Packaging Materials) – Annexure VI
Stock Register raw material – Annexure VII
Stock Register packaging material – Annexure VIII
Test request raw / packaging materials – Annexure IX
Checklist of raw / packaging materials – Annexure X
Material receipt & inspection note – Annexure XI
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance & Production
Annexure – I
From: RM – Ware House
Please verify the quality of the received material with respect to the physical appearance and integrity as mentioned below.
- Name of material
- Manufacturer’s name & address
- Supplier’s name & address
- Batch size (UOM) and no. of containers
- inference containers (If any)
Observations of Quality Control:
Observations of Quality Assurance:
Inference material Ok/ Not Ok or partly accepted for receipt.
GRN No. _____Date _____PO No._______Invoice /Challan No. & Date________
Name & address of supplier: _______Name of the manufacturer:____________
Check the following:-
- a) Tally the No. of container received against qty. as per Challan/Invoice. Yes No
- b) The container label, particularly with Challan/Invoice
- c) Note the material breakup and No. of containers received as per challan/Invoice:
- Name of Material
- Item Code
- Batch no
- Exp. Date
- No. of Containers
- d) Is any container damaged/short? Yes No
- e) If yes
- Name of Material
- Batch No.
- Damaged / Shortage Qty. (UOM)
- No. of Good containers
- No. of Rejected containers
The extent of the damage:
- f) Is damage to the outer covering only? Yes No
- g) Has the material been contaminated with dust, fibers, and pieces of packaging material?
Name & signature of the person who carried out the inspection_____________
Signature of warehouse in-charge____________
Note: This report should be presented to the quality control personnel when he visits the warehouse for a sampling of items received vide this delivery challan/invoice in the report.
Signature of Q.C. personnel carrying out sampling____________Date & Time____________
- Name of Material
- PO No.
- Mfg. Name
- Name of supplier
- Batch No.
- GRN No/ Date
- Name of Material code
For More Pharma Updates Visit –https://pharmaguidances.com