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Receiving the raw materials and packaging materials

  • Receiving the 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 at (Pharmaceutical Company Name).

  • Responsibility:

Raw Material and Packing Material warehouse personnel is responsible for receipt of raw materials and packing materials.

  • Accountability:

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

  • Procedure:
    • 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

  • Distribution
    • Master copy                –           Quality Assurance
    • Controlled copies        –           Quality Assurance &  Production
  • History
Date Revision Number                   Reason for Revision
                      New SOP

Annexure – I

S.No. Date Name of person Party Name

 

Vehicle

No. /

 L.R. No.

Invoice

No. / Chelan No.

security

S. No. for 

material

Name of Material Qty.

( In UOM)

Type of Material In Time Security Sign. Received

 by

(Date & sign)

  Annexure -II

Company Name

Company Address

Our C.S.T. No.: Sr. No.
Our LST: Date

 

Consignee: __________________________________________________________

Party’s C.S.T. No.:_____________________________________________________

Through: ____________________________________________________________

Sr.No. Material Description Unit Quantity Approx. Value Remarks
 

 

 

Purpose: __________________________________________________________________

Tentative date of return: _____________

 

Prepared by          Checked by                      Authorized by                     Received by

 

Annexure – III

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 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:-

  1. a) Tally the No. of container received against qty. as per Challan/Invoice. Yes        No
  1. b) The container label particular with Challan/Invoice
  1. c) Note the material breakup and No. of containers received as per challan/Invoice:
S.No. Name of Material Item Code Batch no Mfg.

Date

Exp.

Date

No. of Containers Qty.

(UOM)

 

  1. d) Is any container damaged/short? Yes No
  2. e) If yes
S.No. Name of Material Batch

No.

Damaged / Shortage Qty.(UOM) No. of Good containers No. of Rejected containers Remarks

Extent of damage:

  1. f) Is damage to the outer covering only? Yes No
  2. g) Has the material been contaminated with dust, fibers, and pieces of packaging material?

Yes                        No

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

S.

No

GRN No/ Date MRN

No/

Date

Name of Material Code PO No. Mfg. Name Name of supplier Invoice No.&

Date

Batch No. Qty.

(UOM)

Mfg. Date Exp Date A.R. No. DTC*

 

Ledger No. Sampling

Date

Q.C. Status Price (INR) Sign

* DTC: Duplicate Transporters copy

                                                              Annexure -VI

S.No GRN No/ Date MRN

No/ Date

Name of Material code PO

No.

Mfg.

Name

Name

of Supplier

Invoice No. & Date Qty.

(UOM)

Pack

Size

A.R. No. Q.C. Sample

Date

Q.C. Status Ledger No. Excise

Bill Receipt Date

Price

(INR)

Sign

                              

                                                               Annexure -VII

Name of Material_________________                                  Item Code_______________

S.

No

Date Mfg.

Name

Name of supplier Invoice / Challan No. Batch No. Qty.

(UOM)

No. of Units

 

Price

(INR)

Mfg. Date Exp. Date A.R. No. Retest Date Date Name of Product Batch No. A.R No Qty. Issued Balance         Qty of

A.R  No

Closing balance

       

                                                                  Annexure -VIII

Name of Material____________________                             Item Code_______________

S.

No

Date Mfg.

Name

Name of supplier Invoice / Challan No. Price

(INR)

Qty.

(UOM)

No of units A.R. No Date Product Name Batch No. Qty. Issued Balance

Qty

of A.R. No

Closing Balance

 

                                                            Annexure – IX

 
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 – 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
  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.No Particulars

Yes

No

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:
Date: Date: Date:
Transporter:                                                                                                                 Vehicle No.
S.No Description Quantity Received Quantity.

as per Challan/

Bill

Price

(INR)

Total

Amount

(INR)

Q.A.

Remarks

Accepted Rejected Total
 

 

 

 

 

 

Prepared by           Inspected & Approved by                      Authorized by 

(Ware house)                (Ware house)                                   (Plant Head)

 

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About Pharmaceutical Guidanace

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

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