SOPs

Receiving of Raw Material & Packing Material

Receiving of Raw Material & Packing Material

Objective

  • To lay down a procedure for receiving of raw material & packing material.

Scope

  • This SOP is applicable for receipt of raw material & packing material to warehouse of formulation plant

Responsibility

  • Warehouse personnel shall be responsible for receipt of raw material & packing material.
  • QC personnel shall be responsible for sampling, analysis & approval of RM & PM.

Accountability

  • Warehouse Department In charge & QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

  • QA                              :            Quality Assurance
  • WH                             :            Warehouse
  • RM                              :            Raw Material
  • PM                              :            Packing Material
  • GRN                           :            Goods Receipt Note
  • QC                              :            Quality Control
  • SOP                             :            Standard Operating Procedure

Procedure

Receiving

  • Security personnel shall receive and make entries in ‘Security Register for Incoming material as per Annexure I and shall stamp at the back side of the Invoice / Delivery Challan with serial number, date and signature.
  • The security personnel shall inform the concerned warehouse personnel by telecon regarding the receipt of material.
  • Warehouse personnel shall verify the following against the purchase order and delivery Challan / 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 No. VIII.
  • In addition to above the following checks shall be performed & Material receipt & inspection note shall be filled accordingly as per Annexure No. IX.
  • In case, the raw 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.
  • If there is any abnormality in the consignment of RM & PM, the same shall be sent back to the manufacturer/supplier, along with Challan having the stamp of ‘Gate Pass Returnable / Non-Returnable’ as per Annexure No: II detailing the reason for return.
  • The materials received in open condition shall not be accepted.
  • If any discrepancy found in 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 QC Department as per “Request to QC Department for verification of received material” as per Annexure III & Annexure VIII.
  • 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.
  • Head-Warehouse/designee shall further forward the same to purchase department after due authorization.
  • After above mentioned verification if material is found satisfactory then received materials shall be stored on pallets.
  • 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 (if applicable) as mentioned on the manufacturer label or as per in-house specification.
  • Ware house personnel shall prepare and affix Quarantine label to each container as per SOP on status labeling.

Warehouse personnel shall prepare the Goods Received Note (GRN) by making all required entries as mentioned in respective ERP format, specimen for ERP system format is described as per Annexure

A request of ‘intimation for inspection and sampling of received material (RM/PM)’ as per annexure no. VII, along with ‘sampling cum approval certificate of RM/PM as per Annexure X shall be forwarded to QC department and notifying the specification reference for sampling, testing and approval of the received material.

On receipt of Requisition from ware house, QC personal shall check the Requisition and sample the RM/PM as per SOP.

  • On completion of analysis of received material by QC, the Head QC shall approve/reject/hold the received material on ‘sampling cum approval certificate of RM/PM as per Annexure X.
  • After approval/reject/hold by QC Head, QC personnel shall forward Sampling Cum Approval Certificate of RM/PM with status of material (approved/reject/hold) to ware house and the warehouse personnel shall retained within department for further future reference.
  • QC personnel shall affix the concerned label on the RM/PM accordingly.
  • The warehouse personnel shall maintain all the details of received RM/PM material in Incoming Register for Raw & Packing Material as per Annexure V.
  • Subsequently the approved material issuance for manufacturing, reconciliation and exact stock (final stock) details shall be entered in ERP system, specimen for ERP system format is described under Stock Register for Raw Material/Packing Material as per Annexure VI.

Forms and Records (Annexures)

  • Security register for incoming Material Raw & Packing Material       –    Annexure-I
  • Challan    –           Annexure-II
  • Request to QC Department for verification of received material   –   Annexure-III
  • Goods Receipt Note for RM/PM       –      Annexure-IV
  • Incoming Register for Raw & Packing Material        –     Annexure-V
  • Stock Register for Raw Material/Packing Material        –      Annexure-VI
  • Intimation for Inspection and Sampling of Received Material (R.M./P.M.)  –    Annexure VII
  • Check List for Received RM/PM       –     Annexure-VIII
  • Material receipt & inspection note     –        Annexure-IX
  • Sampling Cum Approval Certificate of RM/PM –   Annexure-X

Distribution

  • Master copy         –               Quality Assurance
  • Controlled copies –               Quality Assurance, Production, Quality Control, RM & PM   Store

History

Annexure-I

Security register for incoming Material Raw & Packing Material

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:

 

S. No.Date
TimeGR NoGR DateInvoice No.Invoice DateParty NameItemsQty.TransportWeightVeh. NoSecurity Sign.

Annexure-II

Challan 

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:
TIN No.  :

CST No. :

No.  …………….                                                                                           Dated: …………………

To,

CST No. …………………………………………

Vehicle No. …………………………

From ………………………………

To.………….………………………

Purpose ……………………………

S. No.PARTICULARSQUANTITY

Received the goods in order.

Receiver’s Signature                                      Authorised Signatory

Annexure-III

Request to QC Department for verification of received material 

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:
                                            Request to Quality Control for Verification of Received Material

To

QC Department

From: 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
Damage/spoilage/shortage containers (If any)
Observations of Quality Control:

Observations of Quality Assurance:

Damage/spoilage/shortage material Ok/ Not Ok or partly accepted for receipt.

Specify:

Prepared by WarehouseChecked  by QCApproved  by QA

Annexure-IV

Goods Receipt Note for RM/PM   

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:
Company:

Vendor:

G.R.N. No.                                

Location

Store

Default P.O.

Supplier Invoice No.

Del. Note No.                                 

Transporter

L.R./A.W.B. No.

Vehicle No.

Gate entry date

Goods Desc.

Package

Gross wt. (KGS)      Tare wt. (kgs)    Net Wt. (KGS)     

Freight

Insurance

Sr.NoDescription of GoodsAR IDPO IDUnitsPackingBatchNo.Mfg.

Dt.

Exp.

 Dt.

Order

Qty.

Invoice Qty.Receive

 Qty.

Order RateBasic

 Rate

Basic ValueSales

 Tax

Gross

Value

Total Net Value :                          Freight  :               Insurance   :            Spl chg :         Spl Disc    :

Cenvat  :           Ed. Value  :              Edu. Cess   :                 HR Edu. Cess:             Others                Basic Value

Store Incharge  :                                               Date & Time

Updated by     :                                                  Authorised by

 

Annexure-V          

Incoming Register for Raw & Packing Material 

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:

 

S.NoName of MaterialPO NoManufacturerName of supplierBatch No.Qty.Mfg. DateExp. DateGRN No./ DateSample Qty.Sampling Done by

Annexure-VI            

Stock Register for Raw Material/Packing Material   

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:
Store CodeItem CodeItem nameUOMGRN DateGRN Batch IDMfg. dateExp. dateManufacture nameQC Reff. No.DateGRN IDGRN vendor nameSupp. Inv. No.Supp. Inv. Dt.No. of
contrs.
Transection IDTransection
Dt.
GRN

Rcv. Qty.

GRL Rcv. Qty.Stock Rcvd. Qty.MIL Qty.Opening
Stk. Qty.
Opening
Stk.Value

Annexure VII          

Intimation for Inspection and Sampling of Received Material (R.M./P.M.)

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:
INTIMATION FOR INSPECTION AND SAMPLING OF RECEIVED MATERIAL (RM/PM)

                                                                                                           Intimation Date :

From             : RM Store/ PM Store 

To                  : QC Department

Sir,

                     You are requested to depute a person of your department for inspection and sampling of the following material to verify its quality :

Item Name                              Batch No.                  :

Generic Name                    Batch Quantity        

Invoice Challan No. & Dt.          No. of Containers    

GRN No. & Dt.                    Total Qty. Received

Manufacturer                          Mfg. Date                 

Supplier                                Exp. Date                   

                                                                                                  Store Incharge     

                                                                                                   Date                           : __________________

Intimation Received By                                Material Sampled By  

 Date                                                                               Date                             

 

Annexure-VIII 

Check List for Received RM/PM

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:

The Material received should be inspected physically for the following particulars:

SNoMaterial DetailsMaterial – IMaterial – IIMaterial – IIIMaterial – IV
Name of Material Received
Batch No.
Date of Receipt
Quantity Received
No. of Container
Checklist for InspectionObservation
1Are containers/ bags tightly closed/ sealed to ensure that there is no spillage?Yes / NoYes / NoYes / NoYes / No
2Are the containers / bags damaged?Yes / NoYes / NoYes / NoYes / No
3Do the following particulars on the Purchase bill/Invoice tally with labels on the containers (If Applicable)

  1. a) Name of the Raw material/Packing Materials
  2. b) Batch No.
  3. c) Quantity
  4. d) Mfg. date
  5. e) Exp. date

f) Name of Manufacturer

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

Yes / No

4Are the contents (weights / measures) of containers as per labels?Yes / NoYes / NoYes / NoYes / No
5Is there any visible sign of the contamination or impurity such as dirt or other foreign material on the containers / bags?Yes / NoYes / NoYes / NoYes / No
Action taken if any (in case of spillage /damage / shortage): ____________________________________    _____________________________________________________________________________________________________________________________________________________________________

Store In-charge: _________                                                                         Q.C. Chemist: __________ Date:                   _________                                                                            Date:                _________

 

Annexure-IX                        

Material receipt & inspection note 

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:
Name of Supplier:P.O. No:Bill No:GR No:
Date:Date:Date:
Transporter M/sVehicle No.
S. NoDescriptionQuantity ReceivedQuantity.

as per Challan/

Bill

Price

(INR)

Total

Amount

(INR)

Q.A.

Remarks

AcceptedRejectedTotal
Prepared by                                        Inspected & Approved by                                                      Authorized by

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

 

Annexure-X  

Sampling Cum Approval Certificate of RM/PM 

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:

ANALYST’S COMMENTS

No. of cont. sampled                        Sample Qty.

Sampled by                                      Sampled on

Analyst’s remarks

Sign. & Date (QC Personnel)____________

QC COMMENTS

A.R. No                                            Date                                                   Potency / Assay

L.O.D / Moisture                                            Approved / Rejected/ Hold

as per Specification No

Analyst Remarks

Retesting due on

QC Analyst:                                                                                                                          Head-QC:                        

Date:                                                                                                                                       Date :

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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