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Expiry date of Lab Chemicals Part 58

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

7 posts Page 1 of 1
Dear All

In CFR part 58 GLP requirements for non-clinical laboratories, there is requirement for the labeling of laboratory chemicals with expiry date.

Do such labeling is also required for the pharma analytical development laboratory?

Please share ur expertise or any guideline etc.

regards
jUST dO iT....

I believe there is that cGMP requirement, but how that expiration date is actually determined is smoke and mirrors.
as GLP requirement and chemicals has been used should have some expiry date determined during method developement. usually opened chemicals has 3 years expiray date including salts Buffer preparation in general specially phosphate expiry date is 1 week from the date of preparation.
I hope this will help you

Thanks for ur reply.

I read 21 CFR 210 and 211 but could not find anything on laboratory chemicals expiry.

Do it required for cGMP labs like ours in pharma product/ analytical method development.

Thanks
jUST dO iT....

Thanks for ur reply.

I read 21 CFR 210 and 211 but could not find anything on laboratory chemicals expiry.

Do it required for cGMP labs like ours in pharma product/ analytical method development.

Thanks
YES it does require for cGMP and as part of Good Laboratory Practice the 21 CFR part 58 will give you general guideline your Laboratory will set a reasonable expiry date as we do in our Lab.
We generally assign a period of 2 years from the date of openinig.This is for solids.For liquids we give it as 1 year.

You certainly won't find detailed requirements like that in 21 CFR 210 and 211. You may find guidance on the CDER web site, but I don't know what offhand. There must also be articles and books available that could help.

Keep in mind that 21 Part 58 and 21 CFR 210/211 have different goals, even though some of the requirements seem very similar. I have witnessed attempts to force a cGMP laboratory into a GLP mold, and it can produce unexpected complications.

In my opinion, any cGMP-compliant laboratory should have an SOP that addresses this issue in detail, but I don't know any universal rules on what that SOP should say. Here are some thoughts.

Most suppliers of laboratory chemicals will not assure the stability of their packaged products indefinitely. When in doubt, follow the supplier's advice. Three years is a common maximum, even for such self-evidently stable items as sodium chloride. This is reasonable, as the packaging itself may not be stable, or moisture may be slowly absorbed or lost through the packaging. Where the supplier recommends a particular expiry, this should be adhered to. Where there is no supplier expiry, no obvious stability problem, and no literature guidance on stability, two years is commonly assumed, but an experienced chemist with adequate access to the literature should give some consideration to each such case.

Correct storage conditions should be assured. Every chemical should have an assigned storage location with reasonably well known (preferably controlled and/or monitored) temperature. Hygroscopic materials should be stored in dessicators equipped with indicator dessicant or hygrometers.

Standards are usually considered separately from "laboratory chemicals", with a separate SOP. However, in my experience, such items as pH calibrations buffers are sometimes considered as standards and sometimes as chemicals, so it is important to be sure everything is covered somewhere. Standards, pharmaceutical or otherwise, should always have an exact expiry (or retest) date supported by (1) the pronouncement of some authority such a national or international standards organization, (2) reliable data from well-controlled scientific studies, (3) an ongoing stability study, (4) broad-based scientific literature, (5) manufacturer's claims (preferably including published data).

Chemicals with stability issues need special attention. Ethyl ether's tendency to form explosive peroxides on exposure to air is the most obvious example, but others wil be evident on consideration or from experience.

Any laboratory chemical stability issue that has led to a laboratory investigation should have special precautions added to the SOP as part of the corrective action.

Periodic inventory of the laboratory chemicals should be performed to assure that all are properly stored, none are expired, and none have visually decomposed or become contaminated through use.

First-in, first-out should be general use policy. Tracking each individual chemical bottle in and out of the laboratory has not been common practice, but with the prolliferation of bar codes and increasing computerization of compliance, it can only be a matter of time before the standard of compliance reaches this threshold.

It is important to acknowledge that a solution of a chemical preprared in the labroatory is not the same as the packaged chemical, and different rules must apply. There may need to be a separate SOP, but since solutions are often prepared to use in an individual method, the method documents may be the place to address this.

Microbial stability is distinct from chemical stability, and should be treated separately. Microbial growth is opportunistic. If sterility can be assured, materials that should otherwise be discarded after only a few hours can be kept for months. Generally, if microbial growth is favored, there will eventually be a problem with it, but setting specific expiry dates depends very much on the situation. The key thing is not to have an arbitrary (and perhaps ineffective) rule, but to have path towards finding the correct answer. If a packaged chemical is likely to suffer from microbial growth, the supplier will probably address this in some way and may provide guidance. With aqueous liquids, when in doubt, sterile-filter and refrigerate.
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