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Standard Operating Procedure (SOP) for Growth Promotion Test (GPT) of Microbiological Media in Microbiology Laboratory.

Growth Promotion Test (GPT)

1.0   Objective :

• • To lay down a procedure for Growth Promotion Test (GPT) of culture media.

2.0   Scope :

• • This SOP is applicable to check the effectiveness of all dehydrated media purchased in Microbiology Laboratory.

3.0  Procedure – Growth Promotion Test (GPT) :

• • After receipt of dehydrated media check the media for expiry date and seal.

• • Enter the details along with container no. in the media reconciliation record and write the date of receiving on each container.

• • Write date of opening on the container.

• • Each New lot of media shall be qualified for Growth Promotion Test (GPT).

• • Preparation of Culture Suspension:

• • Prepare culture suspension containing 10-100 cfu.

• • Growth Promotion Test (GPT) for Agar Media (Plate Method):

• • Use Wash, clean and dry the required glassware used for microbial Growth Promotion Test (GPT).

• • Prepare & autoclave the required agar media for Growth Promotion Test (GPT).

• • Add culture suspension containing 10-100 cfu for each organism as specified in Table 01.

Also Read : SOP for Technology Transfer of Drug Product

• • Pour 15 – 20 ml of required agar media aseptically under LAF and mix properly by rotating the plate on plate master. Allow the plate to solidify.

• • After solidification incubate all the plates as per time and temperature specified in Table 01.

• • Label a blank media plate as negative control and incubate it at a temperature as specified in Table 01.

• • Observe the plate for growth and note down the result in Annexure-I.

• • Growth promoting test (GPT) for Liquid media / broths media (Tube Method):

• • Use Wash, clean and dry the required glassware used for microbial Growth Promotion Test.

• • Prepare & autoclave the required broth media for Growth Promotion Test (GPT).

• • Add culture suspension containing 10-100 cfu for each organism under test as specified in Table 01.

• • Incubate all the tubes as per time and temperature specified in Table 01.

• • Label a blank media tube as negative control and incubate as per time and temperature as specified in Table 01.

• • The media test is considered satisfactory, if growth/ turbidity appear in the promoting/indicative organism and no growth or turbidity appears in Inhibitory organism.

• • The negative control does not show any presence of microbial growth / turbidity.

• • Observe the tubes for growth and note down the result in Annexure-I.

• • In case of any OOS reported during Growth Promotion Test (GPT) analysis, either for liquid or solid media shall be investigated as per Out of Specification.

• • Shelf life and Storage of dehydrated culture media:

• • Dehydrated culture media should be examined carefully before use to ensure maintenance of physical integrity, colour and free flowing nature.

• • Once opened, all dehydrated culture media shall be used within one year from date of opening of culture media and all expired culture media shall be discarded.

• • Culture media shall be store at control room temperature.

Table 01

4.0   Reference (S) – Growth Promotion Test (GPT) :

• • USP 38, volume-1 chapter no. 62.

5.0   Annexure (S)

Annexure  – I  : Growth Promotion Test (GPT).

Medium Name: ……………                                                    Media Code No.: ……………

Batch No. / Lot No.: ……………                                            Incubation Temp.: ……………        

Use Before: ……………                                                         Incubation Period: ……………

Quantity Received: ……………                                             Date of receiving of Media:……………

Quantity Sampled: ……………                                             Dilution label of Used culture:………..

Container / Bottle No. used for test: ……………

Test Started on: ……………

Test Competed on: ……………

Method used: Plate Pour / Tube Method

Dilution of organism strain:  

Negative Control: Growth / No Growth

Remark : The media is suitable / not suitable for further use in testing.

Microbiologist                           Checked By                                          Approved By

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