- 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 receipt of Raw and Packing material to warehouse of formulation plant at (Pharmaceutical Company Name).
Raw Material and Packing Material warehouse personnel is responsible for receipt of raw materials and packing materials.
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 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 ‘Security Register for Incoming RM/PM’ as per Annexure –I and shall stamp at the back side of the Invoice / Delivery Chelan with 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
- Delivery Location
- The material shall be unloaded from the vehicle under 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
Check list of raw / packaging materials – Annexure X
Material receipt & inspection note – Annexure XI
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance & Production
|Date||Revision Number||Reason for Revision|
Annexure – I
|S.No.||Date||Name of person||Party Name
No. / Chelan No.
S. No. for
|Name of Material||Qty.
( In UOM)
|Type of Material||In Time||Security Sign.||Received
(Date & sign)
|Our C.S.T. No.:||Sr. No.|
Party’s C.S.T. No.:_____________________________________________________
|Sr.No.||Material Description||Unit||Quantity||Approx. Value||Remarks|
Tentative date of return: _____________
Prepared by Checked by Authorized by Received by
Annexure – III
From: RM – Ware House
Please verify the quality of received material with respect to physical appearance and integrity of 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.
|Prepared by Warehouse||Checked by QC||Approved by QA|
Annexure – IV
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 particular with Challan/Invoice
- c) Note the material breakup and No. of containers received as per challan/Invoice:
|S.No.||Name of Material||Item Code||Batch no||Mfg.
|No. of Containers||Qty.
- d) Is any container damaged/short? Yes No
- e) If yes
|S.No.||Name of Material||Batch
|Damaged / Shortage Qty.(UOM)||No. of Good containers||No. of Rejected containers||Remarks|
Extent of 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 inspection___________________________
Signature of warehouse in-charge________________________
Note: This report should be presented to the quality control personnel when he visits the warehouse for sampling of items received vide this delivery challan/invoice in the report.
Signature of Q.C. personnel carrying out sampling____________Date & Time____________
Annexure – V
|GRN No/ Date||MRN
|Name of Material||Code||PO No.||Mfg. Name||Name of supplier||Invoice No.&
|Mfg. Date||Exp Date||A.R. No.||DTC*
|Q.C. Status||Price (INR)||Sign|
* DTC: Duplicate Transporters copy
|S.No||GRN No/ Date||MRN
|Name of Material||code||PO
|Invoice No. & Date||Qty.
|A.R. No.||Q.C. Sample
|Q.C. Status||Ledger No.||Excise
Bill Receipt Date
Name of Material_________________ Item Code_______________
|Name of supplier||Invoice / Challan No.||Batch No.||Qty.
|No. of Units
|Mfg. Date||Exp. Date||A.R. No.||Retest Date||Date||Name of Product||Batch No.||A.R No||Qty. Issued||Balance Qty of
Name of Material____________________ Item Code_______________
|Name of supplier||Invoice / Challan No.||Price
|No of units||A.R. No||Date||Product Name||Batch No.||Qty. Issued||Balance
of A.R. No
Annexure – IX
|G.R.N. No._______________||G.R.N. Date______________||Item code_____________|
|Supplied by_________________________________________||No. of container_________|
|Manufactured by_____________________________________||Invoice No._____________|
|Batch No.________________||Packaging status__________||Invoice Date____________|
|Mfg. Date________________||Exp. / Best before / Revaluation date___________________|
Analysis required as per specification no:
|No. of cont. sampled_____________________||Sample Qty.___________________________|
|Sampled by____________________________||Sampled on___________________________|
|A.R. No._________________||Date________________||Potency / Assay___________|
|L.O.D / Moisture________________________||Approved / Rejected_____________________|
|as per Specification No:____________________________|
|Retesting due on________________________|
|QC Analyst Head-QC|
Annexure – X
1.Material Name : ________________________________Code:________________
2.Type of Packing: _________________________ Total Qty :_______________
3. Check the following details
|S.No||Batch No||Mfg. Date||Exp Date||No of units||Qty.(UOM)||Remarks|
- C.No./Inv. No. : ______________________Date:_________________
- Supplier’s Name : ____________________________________________
- Manufacturer’s Name : ____________________________________________
- Transporter’s/Courier’s Name : ______________________________________
- R. / Docket No. : _______________________Date: ________________
- GRN No. : ______________________ Date:________________
- Check whether following conditions Complies or Not comply:
|1.||Certificate of Analysis by manufacturers has been Attached|
|2.||Duplicate For Transporters Copy Attached|
|3.||No any other material found in the vehicle|
|4.||There is no any Contamination in the Vehicle|
|5.||Vehicle is properly Covered|
Specify (Damage, Wet condition, Leakage, exposure of material to environment, status of labeling and Shortage if any):
(Checked by Ware house / Date)
Annexure – XI
|Name of Supplier:||P.O.No:||Bill No:||GR No:|
|Transporter: Vehicle No.|
as per Challan/
Prepared by Inspected & Approved by Authorized by
(Ware house) (Ware house) (Plant Head)
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube