[mikethair]

I agree @aperson   “the person who really knows whether or not that RH meter needs to be controlled, is the owner of the plant.  Not the inspector. “

And added to that, we are the ones that need to make a profit within the framework of the GMP Guidelines.

Interesting outcome.…I usually allow my QC Manager to deal with these guys when they visit our production facility for these audits. I drop in periodically to see how things are going. On one visit they were hammering her on the RH meter and calibration of these. I stopped the conversation and said something along the lines of “Stop. Deep breath guys. Now look around you…. we are not in a pharmaceutical/vaccine producing facility, we produce simple cosmetics. I now challenge you to check all the specs of our ingredients, and tell me how many specify RH storage conditions?”

We received the written report last week. This issues was not included. Case closed.

[mikethair]

Sure @em88 there are many products that have RH in the storage conditions. Fact is, I have checked every ingreidentwe have, and not one has storage conditions specified for humidity.

“why not have a good working environment for yourself and/or workers?” … agreed. But isnt this a bit outside of what should be a GMP focus? And according to the GMP inspectors “these Hygrothermometers need to be calibrated by a licenced company on an annual basis.”  For what purpose is my response.

Let’s stay focussed.

 

[mikethair]

I’m originally from Perth, and appreciate your isolation. I’d give labfriend.com.au a try. I now live on an island where we have cosmetics manufacturing facility, and find labfriend very useful. Have made some siginifant purchases. Top grade equipment, good prices.

[mikethair]

Why not saponify an oil, for example extra virgin olive oil, and leave out all the other stuff?

 We do this and it is a huge success for our own brand and the other OEM brands we manufacture for.

[mikethair]

Thanks @Belassi  @em88 @”DRBOB@VERDIENT.BIZ”     confirms my toughts. OK, will go into battle with these GMP compliance guys.

I guess on the positive side, they found such piddly items and nothing too significant, so that must be good. They also mentioned that we need to have our AC’s calibrated…. crikey!!!

[mikethair]

Thanks for your comments @em88   In response:

Why do you need GMP if you are not making anything special?

All cosmetics production requires GMP in Malaysia, where we are located.

It is strange that you don’t have  any ingredient that does not specify the storage condition including RH. 

Temperature, yes. Its just a fact, I have gone through our ingredients store checking every label, plus the CoAs, and non stipulate RH.

What common ingredients would, in your view, stipulate RH storage conditions?

Calibration is mandatory for any equipment you declare.

Why calibrate for a parameter that is not stipulated for any ingrerdients?

[mikethair]

In response to @Belassi  @tanelise  once you make a purchase there is no interest from Chinese brands in service, warranty issues, or replacement parts. I must be a slow learner, the same happened with our Chinese autoclave. Nothing but trouble from day 1, plus I found out later that the company did not provide the appropriate Government safety certificate for pressure vessels of this type. Therefore the entire transaction was illegal and left us open to prosecution. Chucked it into the rubbish, and have putchased a European made Autoclave.

[mikethair]

I learnt the hard way, and now steer clear of Chinese equipment.

We have had success with Waring Big Sik Heavy-Duty Immersion Blenders - http://www.waringcommercialproducts.com/catalog.php?pcID=90

Others I know in the industry use these. They are robust and reliable.

[mikethair]

We produce “natural” products under fairly strict and frequently audited GMP compliance conditions. Most of our products have an expiry date of two years. We run the standard Rapid Stability Testing methods, plus I like to ro Real Time as well. 90% of our production business is OEM/Private Label.

To your question, “I am being asked to formulate natural products with expiration of 2-3 years?  How is that possible to predict this before stability is done?”  Unless you are doing something really left-field,  I would be guided by what is already in the marketplace.

[mikethair]

Hi Andy77,

Yes, we are manufacturing in Malaysia and may be able to assist. Most of our business is producing for other brands locally and internationally.

Kind regards,

Dr. Mike Thair
Chief Formulator
Indochine Natural Sdn Bhd

[mikethair]

“the first ever truly natural 100% preservative free face wash”…. not quite true.

We have been producing one for years. You can check the ingredient list here: http://indochinenatural.com/shop/patchouli-lavender-face-wash-250-ml/

The sad thing with the brand mentioned here is  the ‘hypoallergenic,’ ‘MIRR selective microbe claims’ and ‘preservatives are bad’ hype. Our approach is to produce what we do, and have the product speak for itself. Our face wash sells very well under our own brand and a few other brands. At the end of the day consumers (in my opinion) are not so concerned about technical features, but are more interested in what works for them.

[mikethair]

OK, I have been in your position exactly some years ago. Firstly, you need to work this out for yourself. My approach was as follows:

(1) Set up the production facility to meet GMP requirements.
(2) Set up your QC system and testing protocols etc.
(3) Start working with recipes in small batches to see what works, what doesn’t, and test the product results. I started with 6 Kg batches in stainless steel pots.
(4) Scale up to bigger batches in stainless steel pots to see if your selected recipes are reproducible. Check your testing protocols.
(5) If all OK, then scale up to your 250 L tank.

Along the way you will learn a lot, including modifications to your production facility and equipment.

Another point….. check the marketplace. What is your unique selling point with your recipes? If nothing too unique, then maybe consider contract manufacturing.

Remember, it can be done…. but requires persistence. Also, if you can have a peek at another production facility, this can be helpful.

[mikethair]

We have had a similar experience, although not with the product type you mention. In our case it was not an issue of product incompatability, but an issue of defective packaging. 

[mikethair]

Good suggestion @DAS will give SLES 25% a go.

[mikethair]

Yes @Chemist77 acid indeed. At 1% the pH was around 2. Will pose problems probably in our bottling machine.

@DAS  the natureof our product requires something anionic (I think). Will search for other alternatives.

[mikethair]

Not needing preservatives does not apply to just anhydrous products.

Check out ISO 29261 (Second edition 2017-03) “Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products”

These include soaps (liquid and solid) considered low risk because of low water activity and high pH.

[mikethair]

Who cares. You could spend a lifetime chasing these types of brands. My approach…. focus on mmy own brand and get on with it.

[mikethair]

Yes @Perry, agreed, not soluble. So seems a myth perpetuated by ingredient suppliers and as @ozgirl mentions, by bloggers.

[mikethair]

With our new hair conditioner recipe, at room temperature (around 30 C here in the tropics) it appears stable after 8 weeks. However, put it into our 45 C rapid stability test oven and it seperatesinto two layers fairly quickly.

Would I be correct in assuming this is normal for some hair conditioner recipes?

Does present us with a dilema. Dop we only then do room temperature testing? And for how long?

[mikethair]

Thanks for your tip @Bill_Toge, but from my experience if Croda have an agent in Singapore who deal with middlemen in Malaysia, then the Croda agent in India will be unwilling to deal with me. Have had this situation with other global companies. 

Anyway, have sent an email to Croda UK…… will see if I get a response. I do not expect this to be resolved, but at least Croda should be aware, and will be an indication as to if they even care.

[mikethair]

We are a small manufacturer, GMP certificated, and aware of the EU requirements. We export to a few countries.

My company, Indochine Natural, started in Viet Nam as a home based operation where I “fiddled” and developed basic recipes. We then graduated to a small production facility and implemented a full QC system. Next step was to set up a production facility in Malaysia.

In my opinion, I think that a home operator  would find it very difficult to comply with all of the requirements and Safety Assessment of EU Cosmetic Product Notification.

Would love you to prove me wrong though……

[mikethair]

Well @Bill_Toge & @Chemist77 ….. I did give Croda a try. They have headquarters in Singapore and they very effcientlyhandballed me to an agent in Malaysia. Using  the typical Malaysian supply mode menatlity of Traders, when I requested a powder/dry form of protein, they provided a quote and technical literature for a aqueous form. An email from me asking if they had the dry Croda protein, the answer came back in one word…”No.” I did not see any offer of sourcing the Croda product, etc etc…. just a simple “No.”

Conveyed this to the office in Singapore who then contacted the Malaysia rep. He then spun a yarn to Singapore of having conatced me via phone and that all was cool, no problems. Of course they didn’t.

Its a loooong way from UK, and I wonder if Croda are aware of local agents tarnishing what I would imagine is a good Croda brand name?

[mikethair]

Thanks @Bill_Toge & @Chemist77 ….. will give Croda a try.

[mikethair]

Hi ozgirl……we source from Australia (I’m an aussie)….. can you provide any suppliers in Oz for hydrolyzed wheat proteins? Crikey, hydrolysed wheat proteins for ~$75/kg…..

Our current supplier is New Directions in Oz (Sydney).

Thanks.

[mikethair]

I take a different approach with INCI names. In Malaysia we need to Notify products online with the Cosmetics section of the Ministry of health. My starting point is always their online INCI database of accepatable ingredients and INCI names.  If it is not on this database, the Notification cannot proceed. One could go through the process of having them add a new ingredient, but not a hassle I would want to take on.