FDA and cGMP regulations

[oncoming storm]

I have been trying to find what the FDA requires for the labeling and storage of reagents used to test products. Specifically Indicators, standards, mobile phase components, and other stuff you use in the acutal testing of your pharmaceutical product. Anyone know what regulation governs that if any?

Thanks

[JGK]

This may be what you are looking for (it's part of 21 CFR part 58, the GLP guidelines)

http://edocket.access.gpo.gov/cfr_2001/ ... r58.83.pdf section 58.83

This will not replace any additional labelling eg WHMIS which may be required

[Consumer Products Guy]

My guess is that USP and FDA assume that everything is made fresh the day of use. But since it's USP and FDA, they don't say one way or the other (what a surprise !!!).

Therefore, my guess, and it's just a guess, is that USP and FDA expects solutions to be fresh unless one has himself actually documented the stability of such solutions. And of course USP and FDA likely don't provide any details how to do that....

[oncoming storm]

Thanks for the replies. The link is exactly what I have been looking for.

My next question is; how do you determine what is "out of date" when manufacturers don't put expiration dates on their labels?

[JGK]

Thanks for the replies. The link is exactly what I have been looking for.

My next question is; how do you determine what is "out of date" when manufacturers don't put expiration dates on their labels?

A lot of maufacturers/suppliers are providing certificates with expiry or retest dates which helps.

Similarly a lot of companies have default time periods (ours was 5 years) for chemicals where information is not available or provided (either in the CoA or MSDS).

Failing that, e-mail or phone the technical support desk and ask.

[cjwitt]

Thanks for the replies. The link is exactly what I have been looking for.

My next question is; how do you determine what is "out of date" when manufacturers don't put expiration dates on their labels?

When the reagent label and the CofA for the reagent don't specify a expiry or retest date, we use 5 years also. This usually applies to things other than VS's (which almost always have a manufacturers expiry date).

I think the general practice for the manufacturers of reagents is to do 60 month stability testing of their products. This would back up the general 5 year expiration date after opening. Of course there are reagents that arent stable (pyridine, unstabilized THF, unstabilized chloroform) and USP will generally take care of this by stating to use a fresh preparation or freshly opened bottle.

You really need an SOP since there is not really a hard fast rule for this.