00:00 - 00:09
As a manufacturer of ingredients for cosmetics, we of course have to comply with the FDA, CFR 21, you know, the Food and Drug and Cosmetics Act.

00:09 - 00:20
But there's also in order to give customers the confidence that what we're making is of high is, is high quality product. We need to make sure that we're adhearing to the good manufacturing processes as well.

00:20 - 00:31
Part of that process involves making sure the quality management system is is standardized and in place and is able to be recognized by external customers.

00:31 - 00:38
And that's why you also have to follow ISO 9001:2015 QMS requirements too.

00:38 - 00:56
Between the ISO 9001, the ICH Q7, CGMP Standards for quality for active pharmaceutical ingredients, we have a lot of different regulatory and quality standards that we have to be in compliance with to to manufacture our products.

00:56 - 01:03
The most difficult one by a long shot. And it's not unexpected is ICH Q7, CGMP.

01:03 - 01:13
Whenever you're involved with the manufacturing of active pharmaceutical ingredients in the United States, zinc oxide and titanium dioxide are considered active pharmaceutical ingredients.

01:14 - 01:18
And so we have to follow a higher standard than most cosmetic companies as it is.

01:18 - 01:24
That's always been the challenge because this is the same standard used by pharmaceutical companies.

01:24 - 01:36
So, it's about weighing the requirements that are more designed for drug manufacturers being used internally versus a topical sunscreen.

01:36 - 01:39
The scope of requirements increases a great deal.

01:39 - 01:47
Whereas before you're in the standard ISO 9001 quality management system, you're worried about just documentation of calibration for your instruments.

01:47 - 02:05
Well, now you need to be able to not just validate but show documentation of your validation, extensive validation through standard IQ, OQ, PQ type of process qualifications, which is extremely resource intensive process, but it's something that's absolutely required to be compliant with CGMP.

02:05 - 02:18
You have stability testing requirements a long term stability as well that needs to be consistently validated over and over and over again to ensure that the drug that's being outputted is of a consistent quality as well.

02:18 - 02:34
That's also very resource intensive. There's a lot of long term testing and stability controls that need to be put in place that most smaller cosmetic manufacturers aren't necessarily equipped to deal with, that pharmaceutical companies are just used to doing all the time.

02:34 - 02:44
And so the resources, the equipment, the capital expense required to be able to have those systems put into place and work effectively in your facility is significantly higher.