Manufacturing Made Simple Podcast
Aug 19, 2026 · 25 min · 8 segments
Safety, efficacy, and stability testing across both industries — Andrew covers challenge testing, preservative efficacy, ICH Q1A stability protocols, in-vitro versus in-vivo testing, and how to…
Andrew CheungHost
[upbeat music] Now, let me start with something that sounds obvious but is violated more often than it should be.
In other words, it is not just a checkbox to gloss over, but it really is a mechanism by which you move from assumptions to having concrete evidence.
You see, when a formulator develops a product, they are making a series of informed predictions.
They predict that the combination of ingredients will remain stable at room temperature for two to three years or six to 12 months after opening.
They predict that the preservative system will prevent microbial contamination throughout the product's shelf life.
They predict that the active ingredient will remain at its intended concentration from the day of manufacturing to the day that it's being used.
And they also predict that the product will be safe for consumer use under normal and reasonably foreseeable conditions.
Now, just because they are predictions doesn't mean that the formulator is grasping at nothing, because the reality is they are basing a lot of this information off of education and experience.
They're based on ingredient knowledge, expertise on formulation type, and also scientific understanding.
Testing, however, is what converts those predictions into evidence, and in both personal care and pharmaceutical manufacturing, evidence is what you present to regulators, what you defend if something goes wrong, and really is what protects consumers from harm.
Testing is also one of the primary roadblocks to speed to market and something that unfortunately many brands and manufacturers cut corners around based off of having barely any or barely enough data points to proceed with launch.
The testing program for a product needs to be designed before formulation is finalized, not after.
And I want to say this again because it's one of the most consistently violated principles in product development.
The testing program should be designed before the formula is locked because the testing requirements should inform formulation decisions, not simply validating them after the fact.
A stability protocol that requires specific storage conditions may not be compatible with the packaging that you've already committed to.
These are the connections that need to be made early while you still have time to act on them.
[upbeat music] Now, let me start with something that sounds obvious but is violated more often than it should be.
In other words, it is not just a checkbox to gloss over, but it really is a mechanism by which you move from assumptions to having concrete evidence.
You see, when a formulator develops a product, they are making a series of informed predictions.
They predict that the combination of ingredients will remain stable at room temperature for two to three years or six to 12 months after opening.
They predict that the preservative system will prevent microbial contamination throughout the product's shelf life.
They predict that the active ingredient will remain at its intended concentration from the day of manufacturing to the day that it's being used.
And they also predict that the product will be safe for consumer use under normal and reasonably foreseeable conditions.
Now, just because they are predictions doesn't mean that the formulator is grasping at nothing, because the reality is they are basing a lot of this information off of education and experience.
They're based on ingredient knowledge, expertise on formulation type, and also scientific understanding.
Testing, however, is what converts those predictions into evidence, and in both personal care and pharmaceutical manufacturing, evidence is what you present to regulators, what you defend if something goes wrong, and really is what protects consumers from harm.
Testing is also one of the primary roadblocks to speed to market and something that unfortunately many brands and manufacturers cut corners around based off of having barely any or barely enough data points to proceed with launch.
The testing program for a product needs to be designed before formulation is finalized, not after.
And I want to say this again because it's one of the most consistently violated principles in product development.
The testing program should be designed before the formula is locked because the testing requirements should inform formulation decisions, not simply validating them after the fact.
A stability protocol that requires specific storage conditions may not be compatible with the packaging that you've already committed to.
These are the connections that need to be made early while you still have time to act on them.
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