Dear Jesus,
Good Morning!!
The significance of microorganisms in nonsterile pharmaceutical
products (Solid DOsage Form) should be evaluated in terms of the use
of the product and the nature of the product.
Microbial examination of nonsterile products are performed according
to the methods given in the texts on Microbial Enumeration Tests 61
and Tests for Specified Microorganisms 62as defined in USP.
As per it, Microbial Enumeration Tests 61- gives details of method
(general methodology to be followed for enumeration), and Tests for
Specified Microorganisms 62- gives details of identification of
specific microorganisms as in Monographs for some articles require
freedom from one or more species of selected indicator microorganisms
such as Salmonella species, Escherichia coli, Staphylococcus aureus,
and Pseudomonas aeruginosa.
Acceptance criteria for nonsterile pharmaceutical products based upon
the total aerobic microbial count (TAMC) and the total combined
yeasts and molds count (TYMC) are given below. (Refer USP 31)
Route of Administration
Total Aerobic
Microbial Count
(cfu/g or
cfu/mL)
Total Combined
Yeasts/Molds
Count (cfu/g or
cfu/mL)
Specified Microorganism(s)
Nonaqueous preparations for oral use
103
102
Absence of Escherichia
For a given preparation it may be necessary to test for other
microorganisms depending on the nature of the starting materials and
the manufacturing process. Hence it is not always MANDATORY to test
for other microorganisms.
In General, For Solid Oral dosage form, Test for aerobic microbial
count (TAMC) and the total combined yeasts and molds count (TYMC)
along with selected indicator microorganisms such as Salmonella
species, Escherichia coli, Staphylococcus aureus, and Pseudomonas
aeruginosa are performed and Submitted in US/EU regulatory CTD
submission and also in ASEAN CTD submission.
Hope this helps to resolve your query to a extent.
Have a great day ahead.
Thanks
Surender
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