What are the quality standards followed at Applechem

This video outlines the stringent quality standards Applechem adheres to in its product development process. Emphasizing compliance with global regulatory requirements and a commitment to safety and efficacy, it showcases the company's dedication to maintaining high-quality benchmarks in the cosmetics industry.

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Transcript

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.

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Transcript

But what we've known from what I experience was, is we were able to get there with the system. We still there with the system. The system has what is needed to provide us what we're looking for, because every company, admittedly, is trying to get compliant. If we educate people, if we get people the education that they need and to get over the fear factor, I think 90% of those things can be resolved because most people will go to what they're most familiar with.What I worked with from a different company, but they're not willing to sit down and look at what the demographics are saying. People are into social media now. People are moving fast into fast paced world. But technologies are still antiquated. So there's a disconnect here, right? So while we're moving at a fast pace at home with dragging at work, so why can't we continue that speed while we at work?If your supplier has issues and you're not informed on time, you want to have an alternate supplier in place. If your suppliers are not qualified, you may not know that that needs to happen. And so when you have an integrated system that speaks to itself and is giving you all this data, you literally have the pulse of the organization in your hands as an executive at a money bound access.

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