Rejection of Raw Materials and Packing Materials

1.0 OBJECTIVE

To lay down a procedure for Rejection of Raw Materials and Packing Materials

2.0   SCOPE

This procedure is applicable to all Raw materials and Packaging materials that are analyzed and rejected in Quality Control .

 3.0     RESPONSIBILITIES

Executive/ Officer QC shall be responsible for the Rejection of Raw Materials and Packing Materials

Head-QC/ Designee shall be responsible for review and ensuring compliance of Standard Operating Procedure.

 4.0     DISTRIBUTION

            Master copy              :   Quality Assurance Department

           Controlled Copy – 1           :           Quality Control Department

5.0             PROCEDURE

Team leader/Executive shall initiate the rejection procedure for raw materials and packing materials if the material is found out of specification.

  •      QC Executive/officer shall prepare the rejection report .
    •       QC executive/officer shall refer the GRN and Certificate of Analysis to prepare the rejection report.
    •       QC will issue the rejection report for raw and packaging material on the basis of physical verification during sampling, out of specification results and  on-line rejection.        
    • QC executive/officer shall assign the rejection report no as follows:
      • WWW/XX/YYY/ZZ-001,
      • Where WWW represents Company.
      • XX represents the rejected material. PM for Packing material ,RM for Raw material
      • YYY represents the running serial number for the rejection report beginning with 001 at the start of each year.
      • ZZ represents the last two digits of the year.
    • Rejection report of material shall be record as per Annexure-2
    • Team leader/Executive QC shall take approval of Head-QC/designee and authorization of Head quality/designee on the rejection report.
    • A “REJECTED” label shall be affixed on the rejected material.
    • Attach a copy of the rejection report to the analytical data sheet.
    • A copy of the rejection report for raw and packaging materials shall be shared to QA and warehouse.

6.0       ANNEXURES

Annexure-1 : Rejection Report for Raw materials and Packaging materials.

Annexure-2 : Rejection Logbook.

7.0 ABBREVIATIONS

QC-Quality Control

QA-Quality Assurance

GRN- Good Receipt Note     

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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