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Raw materials sample - GMP
I would be interested in the general approach to raw materials sampling generally across the industry.
All of our materials are supplied with a CoA and lot #. During a recent meeting with our GMP inspectors they indicated that on the next inspection they would be looking at our lab testing results for raw materials. The materials we use in making liquid and solid soap include NaOH/KOH, various oils, and essential oils. This surprised me, as the cost of testing would be quite prohibitive for a small producer. We do the usual lab tests (contracted out to a registered test lab) on finished products
Any thoughts on this? How extensive would the testing need to be generally, and what sort of regime needs to be established? Testing every incoming material, or every item once or twice a year?
Thanks.
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4 Replies
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that’s very surprising!
we (and every other UK manufacturer I know of) take the results on raw material suppliers’ CoAs as read, and ISO 22716 auditors have never had a problem with that
apart from basic checks for colour, odour and appearance, the only tests we carry out on raw materials are on water (produced in-house, and the most sensitive raw material we use), SLES (for pH, to check it’s the right blend) and dyestuffs for hair colours (to check they’re the right colour when dyed out)
personally, I’d dispute that conclusion
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Here in my country we test our raw materials based on parameters indicated in the COA that we can perform in-house, e.g. pH, color, odor, melting point, solubility and microbiological presence. We were not required to test the assay, lead content etc since these are done on the finished products already. Plus these are quite expensive.
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The only test I would think relevant for soap making is rancidity of oils, which would I suppose mean measuring the amount of free fatty acids. Personally, I use my nose.
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Thanks @Bill_Toge @crisbaysauli @Belassi I feel a bit more confident now.
Issue is that these GMP cosmetics inspectors are all pharmacists and inspect my place as they would for a top-end sterile pharmaceuticals manufacturer.
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