Handling of Returned Raw & Packing Material – SOP

Standard Operating Procedure (SOP) for Handling of Raw material and Packing Material returned from different sections of the manufacturing/production department to stores/warehouse.

Handling of Returned Raw and Packing Material 

1.0   Purpose:

    • To define the procedure for handling of Raw Materials and Packaging Material Returned from the production department. 

2.0   Scope – SOP for Returned Material:

    • This is applicable to all the Raw materials and Packaging materials returned as a result of-
      • On line rejection
      • Change in the production scheduleHandling of Returned Material
      • Leftover materials in case of trial runs
      • Low yields of the final product
      • Primary processing
      • Equipment Breakdown
      • Any other reason

3.0   References, and Annexure:

    • References:
    • In-house
    • Attachments:
    • Material Return Label(RM/PM/Liquid) – Attachment-1
    • Material return memo (RM/PM) – Attachment-2
    •  Delivery memo – Attachment-3

4.0   Responsibilities:

    • Warehouse department shall be responsible for:
    • To follow the procedure of handling of returned material/s.
    • To intimate Quality Control for testing of returned material/s.
    • Quality Control department shall be responsible for:
    • To analyze returned materials.
    • To approve materials through ERP.
    • Quality Assurance department shall be responsible for:
    • To ensure that the Warehouse person keeps returned material/s at the Designated place.

5.0   Abbreviations used in the SOP for Returned Material/s:

    • Abbreviations:
    • FIFO: First In First Out
    • FEFO: First Expiry First Out
    • AR. No.: Analytical Report Number
    • RM: Raw Material
    • PM: Packing Material
    • API: Active Pharmaceutical Ingredient

6.0   Procedure for the Handling of Returned Material/s:

    • Ensure that returned packaging materials accompany the “Material return Memo (RM/PM)”(Attachment -2) duly signed by the packing supervisor while returning the same to the Packing material store.
    • Ensure that returned raw material/s accompany the “Material return memo(RM/PM)” (Attachment -2) duly signed by the production supervisor, returning the same to the Raw Material store.
    • The material/s returned after primary processing e.g. drying /pulverization/coating (eg. Coated Pellets) etc. accompany the “Delivery memo” as per Attachment -3 and store it at the designated place provided for ‘Storage Area for Inprocess materials’ in raw material store.
    • Ensure that the containers or LDPE bags containing the raw materials and packing materials bear the following labels while returning;

      • Name of the material
      • AR No. of the material
      • Batch No. For which the material was dispensed
      • The quantity of returned material
      • The date on which the material is returned
    • Appropriate Raw material labels (Attachment-1) are to be affixed by the concerned department.              
    • Ensure that the loose dispensed API returned from production after a prolonged period.
    • Due to changes in the Manufacturing plan, equipment breakdown, or any other reason should be retest after receipt.
    • The warehouse shall intimate QC through the mail for retesting of loose dispensed API returned from production.
    • Quality Control shall retest and release and approve the material in ERP as per respective SOP.
    • Don’t transfer the returned liquids to the parent container.
    • Store them in a dedicated carboy properly labeled (Attachment-1).
    • Issue the liquids from these carboys only for Sanitization or cleaning purposes if applicable and not for production purposes.
    • Ensure that materials returned as a result of online rejections are pasted with the “Rejected” label from QC.
    • Enter the details in the rejected register.
    • Ensure that the rejected materials are transferred to the area dedicated to rejected material.
    • Ensure that the materials returned are clean, free of dust, properly covered, and in uniform countable bundles or pack.
    • When the raw material or packaging material is required to be dispensed again, issue the returned material first in order to adhere to FIFO for packing material and FEFO for raw material.
    • Note: Overprinted packaging material returned from packaging must not be accepted in the warehouse.

Material Return Label(RM/PM/Liquid) – Attachment-1

  • Material Return Label (Raw Material)
Item Code:                                                                  RAW MATERIAL
 Name:                                               Rcp. No.         :                                                 Dated:

Batch No.        :                                                                      QUARANTINE            

Mfg. Dt.          :                                                                       DO NOT USE

Exp. Dt.          :                                   A.R.No:

Quantity          :        

Mfg. By          :

Supplier           :            

Package No.    :       

Sampled By:                                   Date :

  • Material Return Label (Packing Material)
Item code:                                                                 
 Name:                                                                                                            

Wo Ret No.    :                                                 Dated:

Batch No.        :                                                                         MATERIAL

A.R.No           :                                                                             RETURN           

Lot Sl              :

Pack Instr.       :                       Reason Code:   

Quantity          :                       Unit:                                        Location:        

Gross Wt.        :                       Tare Wt:                                  Net Wt:

Checked By    :                                   Date :

  • Liquid Return Label

NOT TO BE ISSUED FOR PRODUCTION

Name               :                                   AR No.    :

Batch No.        :                                   Qty.          :

Date                :                                   Sign.         :

Material return memo (RM/PM) – Attachment-2

WO issue No. : Department : WO issue date :
WO No. : Mfg. date : Exp. date : WO date :
Dispense Date :
Product : Route Code :
Product code : BOM code : Batch No. :
Batch Size : Unit : Operation : Process :
CHK Store Item code MATERIAL Std. Requisition Qty A.R. No. Pkg. No.

From -To

QTY. ISSUE Total Qty. (Net) Chkd. Prd/QC

RT EXP

No. of Pkgs. Qty. per Kgs.
Gross Wt. Tare Wt.

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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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