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A finished-product specification should connect a measurable product characteristic to a defined quality decision.
The specification should answer:
What are we measuring, how is it measured, what criterion applies, and what happens when the result is outside that criterion?
Depending on the product:
Not every product needs every test.
Microbiology specifications should distinguish between:
These answer different questions.
A product may require count limits, specified-organism requirements or both.
Where composition is relevant, define:
Nutritional composition testing should not automatically be treated as medicinal-ingredient potency testing.
Where relevant, elemental-contaminant testing may include:
The need for testing should be based on product formulation, ingredient sources and quality requirements.
Botanical and agricultural ingredients may require consideration of aflatoxins or Ochratoxin A.
Sampling deserves particular attention because contamination may not be evenly distributed.
Moisture and water activity may be useful where product consistency, storage, microbiological behaviour or stability are relevant.
They should only be included when they support a defined quality decision.
A finished product represents:
raw materials + formulation + weighing + blending + processing + handling + packaging + storage
Therefore, passing incoming ingredients does not automatically prove that the final product will meet every finished-product specification.
Confirm:
Then determine what follow-up testing can help identify the likely source of the result.
A defined set of measurable product characteristics and acceptance criteria.
Where applicable to the product and quality program.
Not automatically.
Confirm the result and sample, review likely causes and select follow-up testing that answers the investigation question.
Speak with PBR about your product matrix, specification and laboratory testing requirements.