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:
  • WW/XX/YYY/ZZ-001,
  • Where WW represents Industries name.
  • 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
  • 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

Rejection Report for Raw materials and Packaging materials.

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

View all posts by Bhanu Pratap Singh →

Leave a Reply

Your email address will not be published. Required fields are marked *

error: Content is protected !!