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  • Heavy metal testing

    Posted by mikethair on May 27, 2017 at 5:54 am

    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.

    johnb replied 6 years, 6 months ago 3 Members · 5 Replies
  • 5 Replies
  • johnb

    May 27, 2017 at 7:53 am

    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.


    May 27, 2017 at 3:12 pm

    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.

  • mikethair

    May 28, 2017 at 3:02 am

    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?


    May 28, 2017 at 3:40 am

    See 21CFR 700.Manufacturer is responsible for monitoring levels as per safety guidelines for heavy metals.

  • johnb

    May 28, 2017 at 7:29 am

    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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