Handling of Rejected Raw and Packing Materials

Standard Operating Procedure (SOP) for the handling of rejected raw materials and packing materials which are rejected due to the Non-conformance of Quality Standards, Online rejection, or Improper storage.

Handling of Rejected Materials (Raw Material & Packing Material)

1.0   Purpose:

    • To define the procedure for the handling of rejected materials (Raw Material & Packing Material).

2.0   Scope:

    • This SOP is applicable for the handling of rejected material ( raw materials and packaging materials) those are rejected due to,
      • Non-conformance of Quality Standards.Handling of Rejected Materials
      • On line rejection.
      • Improper storage.

3.0   References & Attachments:

    • References:
      • In House
    • Attachments:
      • Material Return Memo (Attachment –1 ).
      • Target date extension of destruction note/ material destruction (Attachment- 2) .
      • Rejected Material Register (Attachment -3).

4.0   Responsibilities:

    • Warehouse department shall be responsible:
    • To transfer rejected material to the designated Rejected area.
    • To co-ordinate with the commercial department for a quick return of rejected material.
    • Destruction of the rejected materials as per SOP of disposal of unusable, defective, expired, non-returnable, rejected material, and absolute packing material.
    • Quality Assurance department shall be responsible:
    • To ensure that rejected material is kept in the designated rejected area.
    • To ensure that materials are destroyed as per SOP of disposal of unusable, defective, expired, non-returnable, and rejected material.
    • Quality control department shall be responsible for:
    • To provide the rejection material note.
    • Re-sampling and analysis of on line rejected material.

5.0   Abbreviations used in the SOP for Rejected Materials:

    • QC: Quality Control.
    • QA: Quality Assurance.
    • SOP: Standard Operating Procedure.
    • HOD: Head Of the Department.
    • BOM: Bill Of Material.
    • GIM: Goods Inward Memo.

6.0   Procedure for Handling of Rejected Materials (Raw & Packing Material):

    • On receipt of the material rejection note, check the material for status labels and shift the Rejected material to the Rejected material storage room,
    • Take entry of material in the Rejected Material Register (attachment-3) and keep it in the Reject room.
    • In case of on-line rejection, on receipt of the material return memo (Attachment-1), check that QA has put rejected label on each package indicating item code, Analytical Report No., rejected by and the date and shift the Rejected material to the Rejected material storage room,
    • Take entry of material in the Rejected Material  Register and keep it in the Reject room.
    • After re-analysis, on the basis of the result, if the material gets approved, QC Shall affix “Approved label and material will be shifted to the approved area and locater code where the material to be stored is updated and will also put a remark in the rejected material register (attachment-3) as “Approved” in the remark column.
    • If the material gets rejected, QC will raise the material rejection note and sent it to the commercial department with a copy to the store.
    • Store the rejected material in the designated rejected area of the Warehouse under Lock and key.
    • The key of the Rejected room is available with HOD/ Area

    • Co-ordinate with the commercial dept. for the immediate return of rejected materials to the Supplier/Manufacturer. 
    • Rejected Primary printed packing materials( Printed foil) to be returned to the supplier by drilling on each roll.
    • Non-printed packing material can be returned to the supplier.
    • Ensure the removal of Quarantine/Rejected labels from each container before dispatch of rejected materials to the Manufacturer/Supplier.
    • Inform to QA in case of return of materials
    • For the return of rejected materials to the supplier or manufacturer,
    • Prepare Non-Returnable Gate to pass & Invoice then dispatch the material.
    • Maintain a rejected materials register indicating the movement of rejected materials; separate for Raw and Packing Materials.
    • Secondary printed packing material shall be destroyed through shredding procedure in the scrap yard.
    • Raise the material destruction note and circulate for approval, Complete the activity within 30 days, in case it is not completed within 30 days intimate to QA, and extend the date for the next 30 days from QA head with justification. (attachment-2)
    • After approval of the destruction, note destroys the rejected materials in the presence of a QA person.
    • Complete the activity within 90 days, in case it is not completed take the extension period as applicable. (attachment-2)
    • Destroy rejected secondary printed packing materials after getting authorization from Location Head, Head Operations/commercial, and Quality Assurance.
    • Please ensure that before the destruction of all rejected materials shall be physically verified by QA Officer.

Material Return Memo (Attachment –1 )

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.

Target date extension of destruction note/material destruction (Attachment- 2) .

Destruction note no: .—————————————————-

Initial Target completion date: ——————————————-

Pending activities:  ——————————————————–

Justification for extension: —————————————————-

Revised target  Date: ——————————————————-

Prepared By: —————-                              Reviewed  By——————-

Reviewed By——————                            Approved  By————–

Rejected Material Register (Attachment -3)

SR NO Rejection  Note No Item Code Description AR No G.I.M. No G.I.M. Date Unit
Receipt Qty. Rejected Qty. Supplier Name/Manufacturer  Name Reason For Rejection Remarks Store sign Q.C./QA Sign

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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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