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Heavy metal testing
Are there any generally accepted industry norms for how often heavy metal tests are done on each production line?
Again, having issues in getting a clear answer from our GMP inspector on this issue. They don’t seem to want to define what they would accept as being OK.
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5 Replies
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Heavy metal contaminants are usually detailed in the certificate of analysis from the manufacturer/supplier of the material in question. If not, then demand this, or at least a declaration of limits, from them.
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Agree you should get Cof A form supplier with list and ranges/limits.You cn add Dissolvine GL 47 ac chelate if needed to your product/s if in doubt.
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Yes @johnb and @DRBOB@VERDIENT.BIZ we insist on CoA’s for all ingredients and these include heavy metals analysis.
Are you suggesting then that in the cosmetics industry generally that heavy metal testing of finished products (or a least some sort of periodic sampling) is not required?
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See 21CFR 700.Manufacturer is responsible for monitoring levels as per safety guidelines for heavy metals.
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If you think that heavy metal contamination is coming from your manufacturing plant then it should be incumbent on you to correct whatever is the cause.
Otherwise, providing you have the correct certification, you should not need to carry out analyses yourself.
Setting up a laboratory to analyse trace metals is an expensive and unnecessary overhead.
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