STANDARD OPERATING PROCEDURE FOR MICROBIOLOGICAL TESTING OF RAW MATERIALS, FINISHED PRODUCTS AND INTERMEDIATES

1.0 OBJECTIVE

1.1 To lay down a procedure for Microbiological Testing of Raw materials, Finished products and Intermediates.

2.0 SCOPE

2.1 This procedure applies to the Pharmaceutical Manufacturing Facility of __________________________________________________________________

3.0 RESPONSIBILITY

3.1 Microbiologists.

4.0 ACCOUNTABILITY

4.1 Head-Quality control

5.0 PROCEDURE

5.1 Total Viable Aerobic Microbial Count:

5.1.1 Pretreatment: For freely soluble samples:

5.1.1 Dissolve or suspend 10 g or 10 ml of the sample to be examined in 90ml of sterile Lactose broth media with 0.1% Twin 80.

5.1.2 For samples with antibiotics:

5.1.2.1 Dilute or dissolve 10gm or 10 ml of the sample in 90 ml of sterile Lactose broth media with 0.1% Twin 80.

5.1.3 For poorly wet table samples:

5.1.3.1 Dilute or dissolve 10gm or 10 ml of the sample in 90 ml buffered sodium Chloride peptone pH 7.0 + 0.1% of w/v of polysorbate 80 to solution.

5.1.4 Membrane filtration Method & Pour plate method:

5.1.4.1 Refer GTP.No.:.........

5.1.4.2 Limits: as per individual monograph

5.1.5 For specified Micro organisms.

5.1.5.1 Sample examined to be free from following pathogens as per individual monograph:

5.1.5.2 Escherichia coli.

5.1.5.3 Enterobacteria

5.1.5.4 Salmonella sp.

5.1.5.5 Staphylococcus aureus.

5.1.5.6 Pseudomonas aeruginosa.

5.1.5.7 Refer GTP.No.:..........

5.1.6 Frequency Of Operation:

5.1.6.1 Raw material : As per monograph

5.1.6.2 Finish product: First three batches and every tenth batch or as per requirement.

6.0 ABBRIVIATIONS

6.1 GTP : General Testing Procedure

7.0 REFERENCES

7.1 NIL

8.0 ANNEXURES

8.1 Annexure –I : Total viable aerobic microbial count and specified microorganism test report.





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