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For each case one specific product need stability test for quality control?
I want to know from experts, for each case it is needed test stability for specific product?
*1 Just one test for the formulation.
*2 Evry new production needs test.
*3 Evry chaniging of one lot of an ingredient.
*4 something else.
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4 Replies
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I’d say when in doubt, do a stability test.
For these specific questions.
1. I’m not sure what you mean but yes you need to test every new formulation. You should also test when you have new packaging.
2. Yes, every new production setup should be tested. But you don’t have to test every batch if you are using the same equipment each time.
3. No, but if you change suppliers than you should do a stability test.
4. Whenever there is a change in manufacturing, packaging, raw material supplier you should do stability testing.
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Thanks a lot @Perry44 very useful, for the first point I meant when you make new formulation by first formulation.
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My approach would be to contact the cosmetics compliance authority in your country and ask for details. You could also ask about their standards and requirements for the inspection of your premises.
My company was manufacturing products and doing compliance for companies globally. And I figured that it was safer to sort out the cosmetic compliance before we started manufacturing.
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If your anticipated development is rapid and includes multiple minor changes/versions, you can determine, if technically justified, which modification justify full stability qualification or stability before marketing.
To Mike’s point, it is important to comply to relevant regulations but do not consider government regulations technically useful or valid. Do what is necessary to comply AND look to industry standards to do what is technically valid.
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