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




Dr. Mike Thair
Cofounder & Chief Formulator
Indochine Natural

Comments

  • 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?
    Dr. Mike Thair
    Cofounder & Chief Formulator
    Indochine Natural
  • I cannot see any relevance at all for RH because if correctly stored, none of the ingredients are exposed to the air.
    Design of anti-aging creams, gels, and serums; shampoos; and therapeutic cosmetics. In-house label and box design capability.
  • Agree waste of time.
  • edited April 16
    @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? 
  • @Belassi, What does it mean correctly stored? 
    - stored in compliance with the manufacturer's recommendations.
    Design of anti-aging creams, gels, and serums; shampoos; and therapeutic cosmetics. In-house label and box design capability.
  • 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!!!
    Dr. Mike Thair
    Cofounder & Chief Formulator
    Indochine Natural
  • Best of luck with gmp. Hope everything gets sorted out. 
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