mikethair
Forum Replies Created
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I don’t see anything “natural” in this formulation.
We took a different approach…..saponified plant oils to produce a hand wash. And the advantages included that there was no need for preservatives as the formulation was self-preserving. We manufactured under certified GMP conditions and all microbial tests were met.
And the product was very kind to the skin, with none of the issues you have described.
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Must agree….this is amazingly stupid.
But my question is. If they are producing under GMP Certificated conditions, why aren’t these formulations and supporting Challenge Tests not picked up during GMP audits? In our case, it certainly would be.
My only assumption, therefore, is that this company not producing under GMP Certificated conditions.
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Has Dr Bronner’s brand got it all wrong?
I discovered Dr Bronner’s brand after we started producing our own saponified liquid products. And immediately saw the parallels.
The main ingredients of Dr Bronner’s products are vegetable oils, lye (NaOH or KOH), and essential oils. So, the same as us.
Founded in the U.S. in 1948, Dr Bronner’s is the top-selling natural brand of soap in North America and a leading brand worldwide.
Dr Bronner’s generated nearly $170 million in revenue in 2021 and donated an estimated one third of profits to activist and charitable efforts. A bottle of Dr Bronner’s soap was sold, on average, every 1.7 seconds last year, and a bar of Dr Bronner’s soap was sold every 2.8 seconds.
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Yes, agreed.
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Excellent advice. Thanks.
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In essence, you have not answered my question “what data are you looking for?”
For your information, we follow The EU Cosmetics Regulation and to date have not had any issues selling our products in the EU. The EU Safety Assessment Officer was happy with our data.
And our Certified GMP Compliance requires us to keep retained samples for two (2) years beyond expiry at ambient temperatures. We are in the tropics, so this pushes products to their limits.
And in our two in-house labs (physical chem lab and microbial lab) our Quality Manager would conduct ongoing lab tests every month (for two (2) years beyond expiry at ambient temperatures). This, in our opinion, provides a reasonable assessment of our products to be safe for human health when applied under normal or reasonably foreseeable conditions of use.
And of course, there are our customers. If they detect product issues, we are easily contactable. To date, over 10+ years has never happened.
<div>OK, then what would you suggest as an alternative?</div><div>
Are you a manufacturer conforming to GMP Compliance, and placing products successfully in the EU market?
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When you say “Consumer data? Can you share it?” What data are you looking for exactly? And in what format?
With our Certified GMP Compliance data we have a lot of data going back 10+ years. And it is not clear what you are looking for here.
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Yes indeed, have in-use data going back 10+ years.
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And in response to your question “Do they ever ask questions re. the data?“
Yes, absolutely. During the audit, there will be numerous verbal questions. And these will be followed up with more detailed written questions.
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In response to your question “What is “everything” GMP data? Finished product and raw material
testing? monitoring data? water testing? batch sheets? yield? training
records?”The answer is yes, yes, yes, yes, yes, yes, and yes to each.
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When you ask “What “GMP data” are you sharing?” then it’s everything.
First, ee need to notify the product before it goes onto the market with National Pharmaceutical Regulatory Agency (NPRA). They of course will check the ingredients list and preservative regime.
Next, we have “surprise visits” by the local office of NPRA. Here it’s a case of a phone call saying they are outside and want access. These are short, very focused visits. And all of our records and Batch Manufacturing Records (BMRs) must be available. We can never know what they will focus on.
And finally, we have formal inspections every two (2) years. Here a team from the NPRA Head Office will spend one or two days going through everything.
Across all of these compliance checks, the issues identified with this “stupid company” would be identified.
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We have exported to many countries and most customers are requesting our GMP data in order to conform with local regulations. My assumption is that it is mandatory.
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Thanks again for your response.
Yes, I accept that liquid soap is not immune to microbial contamination, and the reason we manufacture under strict GMP Certified conditions.
Yes, our body wash/face wash/shampoo products are the classic soap, alkaline pH-based composition.
And as a scientist, over the years I have contaminated our finished products with various bacterial strains in our microbiology lab. And all came up negative. And have sent our saponified liquids to external labs for similar testing. All came back negative. This was mainly designed to look at the consumer side potential for contamination in the shower/bath.
I am not a supporter of the “clean beauty” concept and agree that the preservation systems adopted are sometimes questionable, as is the entire “clean beauty” notion.
<div>After starting to produce our saponified liquid products I discovered Dr Bronner’s range of products.
And with their products being sold on average every 1.7 seconds, any problems with saponified liquids I’m confident would have shown up by now. The company was
founded in the late 1940s, so they have been around for a while. Dr Bronner’s
generated nearly $170 million in revenue in 2021, so they are not short on resources.And your statement “Not aware Dr. Bronner has so qualified their systems and wouldn’t take
just their word for it anyway. Their systems don;t impress.” Then what does impress you?And finally, there is a proportion of consumers who are affected by the synthetics in skin/hair care products. These include my wife. And the consumers are generally silent. But we hear them as producers of synthetic-free products that actually work.
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Good question. Pre-made soap noodles have added synthetic preservatives and sometimes other synthetics. Our saponified plant oils are entirely free of any synthetics.
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I think we are wandering a long way from my original premise. As an old scientist (I’m now in my early 70s), I am familiar with the published literature. And again, in our case with our saponified liquid body wash, face wash and shampoo, we are capturing those
consumers who are having reactions to the synthetics. And there are a lot of these consumers as we have discovered over 20 years. And this absence of synthetics far outweighs any other negatives. -
Yes, agree totally that preservation is for consumer protection, and the self-preserving elements of our saponified products fulfil this requirement. Plus, the total lack of synthetic preservatives which are causing consumer issues.
When you ask “What data do you have in that context?” can you please elaborate? What did you have in mind?
And in response to your comment, “you have a totally incompetent and negligent assessor,” I’m not big enough to question these guys. My assumption is that he understands the self-preserving elements of saponified liquids (body wash, shampoo, face wash). And this understanding is fairly consistent across EU assessors as we don’t always have the same safety assessor.
Thanks for your comments.
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It’s nothing of the sort. My post is a simple statement of fact if you bother to read and understand what I have written.
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The microbiology aspect is straightforward and routine. As required by the GMP Certification standards, on every batch produced we perform TAMC/TY&MC in our microbial lab and report on the results in the Batch Manufacturing Records.
Also, periodically, these results are validated by an external, certified microbial lab.
Interestingly, when exporting our liquid body wash, face wash, and shampoo to the EU, the safety assessor never required microbial data as they recognised the anti-microbial aspect.
I hope that I have adequately addressed your question.
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Yes, liquid soap is a ‘product of ages”…….whatever you mean by that. But yes, it has been around for a long time.
And the “revolutional” in my post is the attraction of customers to our body wash, face wash, and
shampoo due to their total lack of synthetic surfactants and preservatives.
We have discovered since we started producing 20+ years ago that many customers have skin reactions to synthetics. And the scientific
literature identified some synthetics as being endocrine disruptors. -
I’m not sure of your point here. When you say synthetic surfactants are milder than soap, what criteria are you using to measure “mildness.”
And are suggesting our data is “anecdotal evidence”? Being a scientist in my 70s, and perhaps I’m out of date, but around 20 years of data satisfying GMP Certified compliance is hardly “anecdotal evidence.”
And from our experience and that of our customers, the formation of
calcium and magnesium salts being detrimental to pipes has not been an issue.And again, the attraction of customers to our body wash, face wash, and shampoo is their total lack of synthetic surfactants and preservatives. And many customers have skin reactions to synthetics. And the scientific literature identified some synthetics as being endocrine disruptors.
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Agree 100%
In our case with our saponified liquids we were capturing those consumers who were having reactions to the synthetics in body wash, face wash, and shampoo. And there are a lot of these consumers as we found out over 20 years.
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Correct. And this includes soap and liquid.
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The high pH is not an issue.
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Self-preserving? Yes. We have produced under GMP Certified conditions for around 20 years, and exporting globally. The pH of these liquid products is around 9.0 - 9.4 which inhibits bacterial growth. And we have microbiol tested every batch. Zero bacterial growth.
The scientific literature says that the skin mantle recovers quickly, this high pH is not a problem
The products? Liquid body wash, face wash, and shampoo.
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Thanks Abdullah.