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Natural Health Products do not all have the same microbiological profile.
A botanical powder, protein supplement, mineral tablet and liquid product may require different testing.
The testing program should be built around:
product → ingredients → specification → microbiological question → method → representative sample
Measures microbial populations.
Depending on the product, this may include:
Evaluates selected microbial targets.
Depending on the product and specification, examples may include:
Depending on product category and specification:
Related Page: USP Testing for Natural Health Products
Raw-material testing may support:
Finished-product testing evaluates the actual manufactured product after:
Passing incoming materials does not automatically guarantee the finished product will meet its specification.
Botanical materials can be affected by:
These factors can influence microbiological variability.
Powders can be heterogeneous.
The sampling plan matters when results will be used to characterize a production lot.
Liquid formulations can differ significantly in:
Liquid format alone does not determine microbiological risk.
It means the submitted sample exceeded the relevant microbiological criterion or specification.
It does not identify the cause.
Review may need to include:
The result applies to the submitted sample under the applicable analytical method.
It does not prove an entire production lot is free of the organism.
No.
Measurement of microbial populations in the submitted sample.
Selected microbial targets evaluated according to the applicable method and specification.
Potentially.
No.