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GMP Inspection - RH Issues
We had a regular GMP inspection last week…. two Health Ministry guys spend a day auditing our factory. We are not doing anything too special….cold process soap, liquid soaps via saponified oils, face oils etc., and very soon a hair conditioner.
Issue that came up was Relative Humidity (RH). In a number of rooms we have Hygrothermometers and record max/min temperature and RH daily. This includes the ingreredient storage, and finished products storage rooms. Allowable min/max temperatures are stated. Their issue was that (1) we have not stated min/max RH, and (2) these Hygrothermometers need to be calibrated by a licenced company on an annual basis.
My argument was that absolutely non of our ingredients has stated RH storage conditions on labelling and CoAs. Therefore, what min/max RH do we stipulate? There are max/min temperature requirements for ingredients, but not finished products, and these ranges are very wide. Putting these two together, I questioned the need to have these Hygrothermometers officicially calibrated.
Would be interested in opinions here from others with GMP rated factories.
Thanks
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25 Replies
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Why do you need GMP if you are not making anything special?
Calibration is mandatory for any equipment you declare.
You have to have normal conditions (temperature and RH if it not required otherwise) in the prodduction site.
It is strange that you don’t have any ingredient that does not specify the storage condition including RH. -
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?
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I cannot see any relevance at all for RH because if correctly stored, none of the ingredients are exposed to the air.
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Agree waste of time.
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@mikethair, that is interesting regarding Malaysia reglementations about cosmetic manufacturing.
I work in a pharmaceutical industry and we manufacture solid and semisolid products so we have many powder ingredients and most of them require normal RH storage. Storage conditions are based in the ingredient properties and package material used to package that ingredient.
Here is an example: https://www.chemicalbook.com/ProductMSDSDetailCB3463970_EN.htm@Belassi, What does it mean correctly stored?
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@Belassi, What does it mean correctly stored?
- stored in compliance with the manufacturer’s recommendations. -
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!!!
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Best of luck with gmp. Hope everything gets sorted out.
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> we have not stated min/max RH, and (2) these Hygrothermometers need to be calibrated by a licenced company on an annual basis.
typical bs.
they see a piece of equipment, and their knee-jerk reaction is where is your “control”. I doubt highly any of your processes, or materials need to have their RH controlled within limits (for safety reasons).If you can rip them off the wall, and nothing changes (with regard to your manufacturing), then you don’t need either.
which would be my argument. if you’re satisfied that removing RH meters is a solution to your objection (no min/max, no calibration); then why would you have a problem with them staying where they are, uncontrolled? they have no application, with respect to the GMP, and therefore are outside your purview.
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you have to wonder, why you are even having this conversation.
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@aperson there are many products that have RH in the storage condition.
http://www.bsibusiness.com/uploads/product/pdf/330_pdf.pdf and it is very common for powders.
Plus, why not have a good working environment for yourself and/or workers? -
for processing concerns sure. you can work around RH issues, in process.
note my actual argument:
“If you can rip them off the wall, and nothing changes (with regard to your manufacturing), then you don’t need either.“
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Given that he’s in Malaysia, I can guarantee you he’s at some point switched his suppliers to buy a slightly more expensive version of an ingredient, simply to address a processing concern related to RH (either packaging, additive, or conversion from RM to oil carrier). Guaranteed. No question, in my mind. If not him, than his supplier.
… the point here, isn’t that many products have RH specced; the point here is that ABSENT A SAFETY ISSUE, the person who really knows whether or not that RH meter needs to be controlled, is the owner of the plant. Not the inspector.
—If he was doing OTC, different story (where’s API’s, need to be dispersed, and may not be homogenized or milled (either due to solid phase, or “molecular” sensitivity to high shear or temperature).
But, he’s doing shampoos. In water.
KISS. Don’t make it your process, more complicated than it needs to be.Thats the difference between an “inspector” and the responsible person, in a plant. The former, think’s hes being “teachable”, when he don’t know shit; and the latter has the best education money can buy.
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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.
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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.
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wink
> And added to that, we are the ones that need to make a profit within the framework of the GMP Guidelines.
indeed if the FDA was willing to subsidize the price differential between a 1.50 shampoo, and the 150 dollar “hospital” shampoo, out of their generous budget (and take), I might be inclined to produce it under pharma regs.
… seeing as they are not so forthcoming with their swag. screw’em.
mandates, without funding, is legalized theft. inspection “notices of violation” not authorized by law, or gmp regulations, is criminal incompetence (at best), straight extortion at worst.
> “I now challenge you to check all the specs of our ingredients, and tell me how many specify RH storage conditions?”…This issues was not included. Case closed.
well done. good luck on the rest of your “issues”. -
@mikethair, if you don’t have to control the RH, why do you have hygrothermometers in the first place? You should have only thermometers.
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mikethair, You can recommend ASEAN COSMETIC GMP TRAINING COURSE. Module 10: storage. depend on specification of product about the condition storage. We usually keep raw in difference site. For example: extract and perfume we keep in cool place at about 26 degree celcius….
All instruments we use in the factory need to calibrate internal/ external
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Exactly correct @khoikhoa …. as stated above, we are in fact in compliance with ingredient strage conditions sated by suppliers.
And @em88 states, ” why do you have hygrothermometers in the first place? You should have only thermometers.” The answer is that it is just useful to know the RH. This does not mean we need to state ranges and do calibrations.
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“The answer is that it is just useful to know the RH. This does not mean we need to state ranges and do calibrations. “
Of course it does. If you don’t have ranges, it means that you don’t need to know the RH.
If you stated the same thing to the GMP representative than it is more than natural they asked for calibration by a licensed company. -
“Of course it does.”
No, it really doesn’t.
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Tell me, is time a control in your procedures?
Do you validate the calibration, of your the inspectors watch?
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In different stages of the manufacturing process time is verified or set (a specified interval of time is set) at the equipments that are used.
If you are talking for well equipped industries, every machine or apparatus is connected to a system and time is monitored.
If you keep bringing up excuses like this, we will end up saying nothing should be calibrated. -
I don’t know anything about Malaysian regulations
but you can either rent a professionally calibrated hygrometer for a couple days to compare readings with your equipment
or you can take your hygrometers to their shop so they can compare readings and somehow certify them in writing, for a fee. -
> Do you validate the calibration, of your the inspectors watch?
Do you validate the calibration, of your the systems clock?
—I’m not making excuses; I’m making a point. You have a far more sensitive “control” that isn’t calibrated at all; in fact, I doubt its even entered your mind to consider it. Which is ironic, given its importance. AND NOT, an RH meter.
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With respect @em88, I am meant to be running a profitable business, and that is 100% my responsibility. This is nothing to do with the GMP inspectors. If we have absolutely zero ingredients requiring RH specified storage conditions, and if I as the factory owner decide that “it is just useful to know the RH” and spend the money, then this does not imply an excuse for them to require third part calibration. Very simply, calibration is not required, it’s that simple.
And “just useful to know the RH” is helpful in determing staff comfort and efficiecy of AC’s. Calibrated equipment not necessary.
“If you keep bringing up excuses like this, we will end up saying nothing should be calibrated. ” Again @em88 we credit people with the intelligence of deciding (based on their particular production facility) if particular items of equipment require calibration.
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well said mikethair.
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@mikethair,
“I am meant to be running a profitable business, and that is 100% my responsibility. ” - There are some rules to be followed. By doing a simple calibration will not shut down your business.
It is very clear that you have made up your mind, so there is no point keeping this up.
Good luck with your issue.
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