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GROWTH PROMOTION TEST

  • PROCEDURE FOR THE GROWTH PROMOTION TEST:
Growth Promotion Test (GPT)
  • A growth promotion test is a quality control procedure used in microbiology. It is a relatively simple test, where the medium is challenged with a small number of microorganisms to assure its nutritive properties and to demonstrate that it enables organism growth.
  • Each dehydrated / ready prepared Media, which is used for microbiological testing should be subjected for Growth Promotion test.
  • Each lot of received medium should be tested for growth promotion as per GTP.Assign GPT Reference Number to each media undergoing for Growth Promotion Test.
  • Assigning GPT Reference Number to Media:
  • All the media undergoing Growth promotion test shall be identified with unique numbering system.
  • The numbering system consists of 14 characters.
  • First three characters “GPT” denote Growth Promotion Test.
  • Next character is a “/” slash.
  • Next three characters denote Name of the Media undergoing GPT.
  • Next character is a “/” slash.
  • Next three characters are the serial number starting from 001 in every year.
  • Next character is a “/” slash.
  • Next two characters “25” denote year 2025.
  • Example: The first Soyabean Casein digest Agar medium undergoing growth promotion test in the year of 2022 shall be numbered as GPT/SCD/001/25.
  • Procedure for Growth promotion Test:
  • Perform the Growth promotion test as per the GTP.
  • Record the results of growth promotion in Format.

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  • In case of failure in GPT for the media, following action shall be taken:
  • If GPT fails fewer than two organisms, re-inoculation with the fresh culture shall be carried out and investigation shall includes Conditions of culture preparation & storage, Conditions of media preparation and Conditions of media sterilization.
  • For any batch of agar that fails to meet GPT criteria on first test and on re-inoculation PNC shall be initiated and investigation shall be performed. During investigation review (but not limited to)- conditions of culture preparation & storage, Conditions of media preparation, Conditions of media sterilization, Other possibly related GPT Incidents and Data obtained in testing using the media in question.
  • Investigate the GPT failure as per Format-II.
  • Based on the investigation necessary corrective and preventive action (CAPA) shall be taken.
  • If the media shows satisfactory growth then the media shall be used for routine analysis.
  • ANNEXURES: 
ANNEXURE NO.TITLE OF ANNEXURE
Annexure-IGrowth promotion test reference number allocation register
Annexure-IIGrowth promotion test failure investigation report
  • ABBREVIATIONS:
No.:Number
SCD:Soyabean Casein Digest Agar.
SOP:Standard Operating Procedure
QC:Quality Control

Annexure-I
GROWTH PROMOTION TEST REFERENCE NUMBER ALLOCATION REGISTER

GROWTH PROMOTION TEST REFERENCE NUMBER ALLOCATION REGISTER

Annexure-II
GROWTH PROMOTION TEST FAILURE INVESTIGATION REPORT

GROWTH PROMOTION TEST FAILURE INVESTIGATION REPORT

Click the link for download word file copy of this document:
https://pharmaguidehub.com/product/growth-promotion-test/

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