SOPs

SOP on Receipt of Raw Materials and Packaging Materials

SOP on Receipt of Raw Materials and Packaging Materials

Objective:

  • To lay down a procedure for receiving the raw materials and packaging materials.

Scope:

This SOP is applicable for receipt of Raw and Packing material to warehouse of

formulation plant.

Responsibility:

Officer or above-warehouse is responsible for receipt of raw materials

and packing materials

Accountability:

Head- warehouse shall be responsible for compliance

and implementation of SOP.

 Procedure:

Security personnel shall receive and make entries in ‘Security Register for Incoming

RM/PM’ as per Annexure 01 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.

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’   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 the manufacturer/supplier in

case of non-availability of the 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”.

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.

Warehouse 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).

A request shall be forwarded to QC department i.e. “Test Request for Raw /

Packaging Materials” as per Annexure 09  notifying the specification reference for

sampling and testing of the received material along with GRN

On receipt of Requisition and GRN from warehouse, QC personal shall check the

GRN and sample the Raw material and Packing material ( SOP on sampling of

Raw material) and  ( SOP on sampling procedure of 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 Warehouse, second copy (pink colored)

to QC  and third copy forwarded (yellowish-green) to Purchase department

Ware house personal shall initiate MRN.

The warehouse personnel shall enter the details in “Incoming Material Register

for Raw material and Packing material  Correspondingly

Subsequently the approved material issuance for manufacturing, reconciliation

and exact stock (final stock) details shall be entered in “Stock Register of Raw Material”

and “Stock Register Packaging Material”   for packaging material.

Security register for incoming RM/PM – Annexure Number -1

Gate pass returnable / non-returnable -Annexure Number -2

Request to QC department for verification of received material -Annexure Number -3

Goods Received Note- -Annexure Number -4

Incoming material register (Raw Material)- -Annexure Number -5

Incoming material register  (Packaging Materials)- -Annexure Number -6

Stock Register raw material – -Annexure Number -7

Stock Register packaging material- -Annexure Number -8

Test request raw / packaging materials -Annexure Number -9

Checklist of raw / packaging materials – -Annexure Number -10

Material receipt & inspection note – -Annexure Number -11

Referance

SOP on SOPs.

Reason for Revision

To enhance the adequacy of SOP and better clarity

Abbreviations and Definitions

RM:           Raw Material

PM:           Packaging Material

GRN:           Goods Receipt Note

SOP:           Standard Operating Procedure

MRN:           Material Received note

R.No:           Analytical Report Number

PO:           Purchase Order

INR:           Indian Rupees

DTC:           Duplicate Transporters copy

LOD :           Loss on Drying

R.No :           Lorry Number

No :           Invoice Number

UOM :           Units of Mode

 

END OF SOP

Annexure Number -1

Security Register for Incoming RM / PM 

S.No.DateName of personParty Name

 

Vehicle

No. /

L.R. No.

Invoice

No. / Chelan No.

security

S. No. for

material

Name of MaterialQty.

( In UOM)

Type of MaterialIn Time

Annexure Number -2

(Gate Pass Returnable/Non-Returnable)

Our C.S.T. No.:Sr. No.
Our LST:Date
Consignee: _______Party’s C.S.T. No.:______Through: ______
Sr.No.Material DescriptionUnitQuantityApprox. Value

Purpose: ______________Tentative date of return: _____________

Prepared by         Checked by       Authorized by       Received by

 

Annexure Number -3

Request to Quality Control for Verification of Received Material 

To

QC Department

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.

Specify:

Prepared by WarehouseChecked  by QCApproved  by QA

 

Annexure Number -4

Goods Received Note for Raw / Packing Material 

GRN No. _____Date ________PO No._______Invoice /Challan No. & Date___________

Name & address of supplier: _______Name of the manufacturer:________

Check the following:-

  1. a) Tally the No. of container received against qty. as per Challan/Invoice. Yes  /   No
  1. b) The container label particularly with Challan/Invoice
  1. c) Note the material breakup and No. of containers received as per challan/Invoice:
S.No.Name of MaterialItem CodeBatch noMfg.

Date

Exp.

Date

No. of ContainersQty.

(UOM)

  1. d) Is any container damaged/short? Yes No
  2. e) If yes
S.No.Name of MaterialBatch No.Damaged / Shortage Qty.(UOM)No. of Good containersNo. of Rejected containersRemarks

Extent of damage:

Is damage to the outer covering only? Yes /No

Has the material been contaminated with dust, fibers, and pieces of packaging material? Yes / No

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 sampling of items received vide this delivery challan/invoice in the report.

Signature of Q.C. personnel carrying out sampling_________Date & Time

Annexure Number -5

Incoming Register for Raw Material 

GRN No/ DateMRN

No/

Date

Name of MaterialPO No.Mfg. NameName of supplierInvoice No.&

Date

Batch No.Mfg. DateExp DateA.R. No.Ledger No.Sam

pling Date

Q.C. Status

 

Annexure Number -6

Incoming Register for packing Material

S.NoGRN No/ DateMRN

No/ Date

Name of MaterialcodePO

No.

Mfg.

Name

Name

of Supplier

Invoice No. & DateQty.

(UOM)

Pack

Size

A.R. No.Q.C. Sample

Date

Q.C. StatusLedger No.

Annexure Number -7

Stock Register for Raw Material

Name of Material_________________                            Item Code_______________ 

Mfg.

Name

Name of supplierInvoice / Challan No.Batch No.No. of Units

 

Mfg. DateExp. DateA.R. No.Retest DateName of ProductBatch No.A.R NoQty. IssuedBalance Qty of

A.R

No

Closing balance

 

Annexure Number -8

Stock Register for Packaging Material

Name of Material_________________ Item Code_______________ 

S.

No

DateMfg.

Name

Name of supplierInvoice / Challan No.Price

(INR)

Qty.

(UOM)

No of unitsA.R. NoDateProduct NameBatch No.Qty. IssuedBalance

Qty

of A.R. No

Closing Balance

Annexure Number -9

 REQUEST FOR RAW / PACKAGING MATERIALS

G.R.N. No._______________G.R.N. Date______________Item code_____________
Material____________________________________________Qty. Received__________
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:                                                          Signature (Warehouse)
SAMPLER’S COMMENTS
No. of cont. sampled_____________________Sample Qty.___________________________
Sampled by_________________________Sampled on___________________________
Sampler’s remarks_____________________________________________________________

Signature (Q.C.)

QC COMMENTS
A.R. No._____________Date________________Potency / Assay___________
L.O.D / Moisture_____________________Approved / Rejected_____________________
as per Specification No:____________________________
Analyst Remarks_______________________________________________________________
Retesting due on________________________
QC Analyst                                                                                                          Head-QC

Annexure Number -10

Checklist of raw & packing materials

  1. Material Name :  ______________________________________Code:_____________
  2. Type of Packing: _______________________________________Total Qty :__________
  3. Check the following details
S.NoBatch NoMfg. DateExp DateNo of unitsQty.(UOM)Remarks
  1. C. No. / Inv. No.                     :  ______________________Date:__________________
  2. Supplier’s Name   : ______________________________________________
  3. Manufacturer’s Name  : ______________________________________________
  4. Transporter’s/Courier’s Name :  ______________________________________________
  5. R. / Docket No.                        : _______________________Date: __________________
  6. GRN No.                                  : _______________________Date:__________________
  7. Check whether following conditions Complies or Not comply:
S.NoParticularsYesNo
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 Warehouse / Date)

Annexure Number -11

Material Receipt & Inspection Note

Name of Supplier:P.O.No:Bill No:GR No:
Date:Date:Date:
Transporter: M/s                                                                                                     Vehicle No.
S.NoDescriptionQuantity ReceivedQuantity.

as per Challan/

Bill

Price

(INR)

Total

Amount

(INR)

Q.A.

Remarks

AcceptedRejectedTotal

Prepared by     Inspected & Approved by        Authorized by( Plant Head)

 

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits 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. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube