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Raw Material Testing Practices
We are trying to figure out how our raw material testing plans compare to others in the industry and what the industry standard is considered to be.We currently sample square root of n + 1 for all lots of incoming materials. We are considering implementing a reduced testing protocol that after 5 or 10 lots have been received and tested new lots only require 1 sample per lot to be pulled. What do others do?For micro we currently test if the material has more than 10% water or if the vendor tests micro. What do others do for micro testing for products? Do you ever put this on reduced testing? -
1 Reply
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<10% water is not a valid micro testing exclusion. Considerations here are not the same as finished product - you’re worried about presence, not just growth. Accept CoA’s only if you trust the vendor and the conveyance from vendor to you is justifiably in control.
Big companies have the resources to qualify vendors and their production and change controls. Likely you’ll have to assume some risk in trusting vendors not to screw up. Suggest you default to test everything and exclude RM’s of obvious hostile composition/production - pH extremes, anhydrous waxes etc. from hot process, salts…. I’d consider dropping tetsing after a history of no recovery AND a technical rational as to why.
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