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Request for Stability Test Methodology/ SOP
As we continue to update our GMP compliance, I was surprised to learn that the lab we have contracted for our cosmetics testing does not provide stability testing services, and suggests that we do our own.
Our company Quality Manager has provided a Stability Test SOP for addition to our Quality System, but I would be interested in comparing this to other methodologies. An online search revealed zilch.
What we are looking for is a simple methodology using a stability oven.
Would be appreciative of being guided in the direction of a simple Stability Test methodology.
Thanks
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6 Replies
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Perry did a webinar on this several months ago that was very comprehensive.
Our stability protocol is based upon guidance from the PCPC. There is not hard set protocol but in general if you make a good faith effort to follow the PCPC guidance you should have a defensible program.
I have also sen facilities perform tests in addition to the guidelines. One example is a calibrated light box.
Lastly, you also have to make some allowances for the type of product. AN quick example of this is perhaps the differences you might employ when testing an anhydrous butter over a shampoo for instance.
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youll need to place your samples in the oven at 45C and check them at 1/2/3/6/12/24/36 months. pH/density/visc/color/etc…. if its OTC then test actives as well. you’ll need both ambient and accelerated data. keep everything in calibration per cGMP
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I would recommend taking a look at the Colipa guidelines for stability testing of cosmetic products. It’s free to download, the link is below:-
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+1 for the COLIPA guidelines
there is no standard because stability testing is not a rigorous science, and is essentially a guessing game; you just have to evaluate all the data as a whole, draw a conclusion from it and make a judgment call based on that conclusion
I’d recommend doing freeze/thaw cycles as well, as it highlights the difference between an intrinsic instability and a heat-related instability, and gives you an advanced alert of any low-temperature instability that might not be immediately evident
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I also know of several Chemists who work almost exclusively in surfactant systems and they rely heavily upon centrifuge testing as well as a full protocol.
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Great, thanks for the suggestions….much appreciated. Also confirms an appropriate mindset as well.
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