PRESERVATIVES

[Guest guest]

I would like to add my 2 cent worth. I have invested a lot of time and money in

my business as I am sure both hobbiests and startup business have also. I look

at the fact that once we pass the boundaries of a " bar of soap " we have chosen

to enter the FDA's territory. FDA can make a drop in visit to any one of our

businesses at any time, all it takes is one complaint filed with them or your

name came up on a random check list. I received notification that I could

expect a visit in this next year. This gave me cause to review my GMP's (Good

Manufacturing Practices). We are all responsible and liable for the products we

produce and choose to sell. Selling does not matter if it is a home party, craft

show, a booth set up somewhere, or some person coming to your home.

I have lurked for a long time and kept my mouth shut, but consider the post

" I guess I will have to get my dogs out of the kitchen " . Aseptic control is

essential in this business, it is not about money, why go to the trouble of

producing a product you feel has great benefit that has the potential of causing

greater harm. If you purchased a product for a loved one or a pet and

experienced devastating results my guess is you would howl and want compensation

of some form. We take great care in developing and producing our products. So

let me plant some seeds for thought:

1] How are your batch records maintained.

2]Do you retain a container of product out of each batch

3] How do you determine the shelf life of your products?

4}] What do your benchmark studies indicated in both a freezing and heated

environment, have you documented them..

5] have you found a way to insure the integrity of your products when placed in

these extreme environments....is the viscosity consistent at months 1 and three?

6] have you had your product at a minimum for contamination, micro-organisms

i.e., seudemonis (pardon spelling) staph germs...and many others. When you see

a problem it is in epidemic proportions.

7] For those of you using well waters or high chemical waters in your

manufacture, what have you done to insure the bacteria in it is neutralized.

When was the last time your well was checked for coliform bacteria....certain

levels of coliform (a form of e-coli) a permissible in drinking water but

consider what you just added to your product....

I am not picking but this is a cottage industry....how many of us would survive

a FDA GMP inspection? What would be the " fining " consequences to our already

strained household budgets. Spend as much or more time investigating how to do

it right....you can be a natural producer....but are you a safe producer...only

testing will determine that. Without just the few items mentioned above, and

there are many more,you will fail hands down. Failure is a stepping stone to

growth, but if that failure causes another person to suffer its consequences to

a potentially life changing devastation, IS IT WORTH IT>

Pam