GMP & Water Quality


We seem to have an over-zealous Government GMP inspector (trained as a pharmacist) and would be interested in the collective wisdom of this group on GMP & water quality.

We produce non-sterile products including liquid soap, and soap bars produced by saponifying plant oils.  We also make a number of other non-aqueous products including face oils, balms, and clays. We plan to do a standard recipe hair conditioner in the future.

We are only a small producer, therefore we purchase Reverse Osmosis (RO) water in 18 L containers that is sold as purified drinking water. Each container has a Lot #, and we are supplied with the water CoAs produced by a Government test lab. The water Lot # for each manufacturing batch is recorded on our Match Manufacturing Record.

The Government GMP inspector has two issues with this approach:

(1) She maintains that this water quality is not good enough for cosmetics and that we should install our own RO water unit and have the water tested regularly. My argument is that for a small producer (a) this is not cost effective, and (b) if traceable bottled drinking water (with CoAs) is not good enough for wash off cosmetics, then why does the Government allow this water to be on the market as drinking water.

(2) She insists that our equipment have a final rinse of RO water. Currently, we use tap water and allow to dry on racks. Again, I argue that given the types of products we are producing, a final rinse of tap water is adequate.

Would be interested in any thoughts on the above issues.


Thanks.


Dr. Mike Thair
Cofounder & Chief Formulator
Indochine Natural

Comments

  • You can buy a domestic RO unit for around $300, you may find it cost effective compared with bottled water. Regarding (2) I'm not in complete agreement because glassware should be disinfected before use, anyway. But if your tap water is highly mineralised?
    Cosmetic Brand Creation. Concept to name to IMPI search to logo and brand registration. In-house graphic design inc. Pantone specs. Cosmetic label and box design & graphics.
  • Bill_TogeBill_Toge Member, Professional Chemist
    as long as you measure the conductivity and microbial counts on each lot, and keep a record, I can't see what else you could do to monitor the quality

    for water testing, you'd need a conductivity meter with a resolution of 0.1 or 0.01 μS

    however, I do agree about not using tap water to rinse your equipment; if your tap water is not subject to microbial control, it can potentially contaminate your equipment and make sterilisation pretty pointless
    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • OK Bill, you don't think that the CoAs (that include microbial counts) associated with the bottled drinking water are inadequate, and that we need to test ourselves?  Or do you mean the CoAs provided with the water are OK?

    And what is the point of measuring conductivity within the context I have described here?

    "Sterilisation"......we are not producing sterile products. The liquid and solid soaps via saponification are not subject to microbial contamination due to their high pH. Most cosmetics compliance systems around the world do not require microbial testing of these types of products.

    What I may do is test our tap water and see if it is contaminated.

    Dr. Mike Thair
    Cofounder & Chief Formulator
    Indochine Natural
  • Bill_TogeBill_Toge Member, Professional Chemist
    @mikethair GMP standards are GMP standards, regardless of what you make - where I work we make perms, peroxides and relaxers, which are inherently aggressive and microbicidal (hence, very low risk), but the same standards still apply

    the CoA proves that your water is fit for use at the source, but as it stands you have no positive proof it's still fit for use by the time it gets to you, which is particularly important with something as sensitive and perishable as unpreserved water - testing the conductivity is a quick and easy way to see whether it's been contaminated

    as an example, we once had to reject an IBC of propylene glycol because there was a dead bird in it

    the CoA said it was fine, and I'm sure the liquid was fine when it was tested, but the product we received was definitely not fit for use!

    admittedly this is quite an extreme example, but the same principle holds
    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • Thanks @Bill_Toge .....point very well taken, and probably a mindset that I need to adopt. Yes, an extreme example, but it makes a valid point.

    Thanks.
    Dr. Mike Thair
    Cofounder & Chief Formulator
    Indochine Natural
  • 1.) It is a must to test the RO water you are purchasing, taking note of the pH, total dissolved solids (TDS) and microbial count. The actual results must match the specifications in the COA your supplier provided.

    2.) Final rinsing with RO water is also a must. Most critical property of RO water is the low TDS, which reflects the hardness of the water you used for cleaning. Also, washing with RO water ensures minimal microbial presence. Emulsions and liquid products like toner are affected very much by TDS. Though installing your own system is a bit too much, if you're saying you are a starting manufacturer. You must also monitor the pH, TDS and microbial count of the tap water you are using.
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