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(780) 450-3957
Testing a raw ingredient and testing the finished Natural Health Product are not interchangeable quality controls.
They answer different questions.
Raw-material microbiology asks what was measured in the submitted incoming ingredient.
Finished-product microbiology asks what was measured in the manufactured formulation.
Raw-material microbiology may support:
The finished product reflects:
Finished-product microbiology therefore addresses the product that was actually manufactured.
| Decision | Raw Material | Finished Product |
|---|---|---|
| Supplier qualification | Strong relevance | Supporting |
| Incoming-lot acceptance | Strong relevance | No |
| Ingredient-source investigation | Strong relevance | Supporting |
| Finished-product specification | Supporting | Strong relevance |
| Manufacturing investigation | Supporting | Strong relevance |
| Product-release decision | Indirect | Depends on specification |
No.
Passing ingredients do not account for:
Likewise, an elevated raw-material count does not automatically predict the finished-product result.
Depending on the product and quality program:
Testing frequency should be determined by the quality program and supplier history rather than one universal rule.
Review:
Targeted raw-material testing may help determine whether ingredient contribution is plausible.
Large botanical or powder lots may be heterogeneous.
One grab sample may not adequately represent the full lot.
Consider:
The sample should support the conclusion you intend to make.
Depending on product and specification:
No.
No.
Potentially, where ingredient contribution is a plausible explanation.
Testing frequency depends on supplier qualification, ingredient risk, historical performance and the company's quality program.
It depends on the lot and sampling design. Composite sampling may also reduce visibility of localized variation.
Tell PBR what product you manufacture, what specification applies and what quality question the testing needs to answer.