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Expiry date vs. Best Before Date - Reagents

SpartanBio

Involved In Discussions
#1
My company makes a reagent that has an expiry date. That expiry date is on our labeling, in what we communicated to the reg bodies, etc. Internally we have a best before date. A date that after we hit that date we don't like to ship it to the customer. Our customers don't require this, we haven't communicated it to anyone (i.e. reg bodies). Now the powers that be want to include the best before date terminology in our documents. Give it as justification for scraping product that hasn't yet expired. I feel like this is not the right thing to do. Any thoughts.

Thanks
Keri
 
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Ninja

Looking for Reality
Staff member
Super Moderator
#2
{snip}...Give it as justification for scraping product that hasn't yet expired.
Sounds like a marketing/obsolescence move.

There's no tight right/wrong in that arena...just shades of grey in the ethical arena.

Me...I wouldn't lose sleep over it, but I would (if able) track complaints and hours spent on complaints vs. increased sales (or profit) suspected to be directly due to this. More out of curiosity than anything else...

If the data was radically compelling, I might try to present it upwards with a raise or promotion as a goal. If the data was overly muddy, I'd ignore it and move on.

Do an internet search on "best by" or "sell by" dates for food...it's all marketing...
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Oh My. I went though many, many hours of meetings on this in my last job.
It's a painful subject sometimes.

The bottom line is if you mark it with an exipry date then you are saying the reagent has lost enough efficacy by that date that is no longer useable for it's stated purpose and it should be discarded. If you want to use it beyond that point you'll need to test it to prove it's still useable and extend the life by a finite amount.


It looks like your power that be want to make the "best by" date sooner than the expiry date? Is that correct?
I've never seen that done... I've seen expiry periods changed, and "best by" dates changed to expiry... but I've not seen this situation.

How is your product regulated? what would be the fallout of a label change?

I would ask for the analytical justification if I was a customer. Show me the testing that shows that the reagent degrades sooner that we thought.
 

Ajit Basrur

Staff member
Admin
#5
refer Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Records and Reports

Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at 211.194, includes laboratory chemicals such as solvents (including mobile phases), dry chemicals (salts, primary standards, etc.), and solutions (buffers, acids/bases, quantitative analytical preparations, etc.), whether purchased or prepared in-house. Laboratory reagents and solutions are used in analytical tests of components, in-process materials, and finished products.

If the purchased laboratory reagent or solution includes a manufacturer’s suggested "use by" or expiry date, that date should be followed. For purchased laboratory reagents and solutions without a "use by" or expiry date, FDA would expect that an assessment be conducted (literature review may be acceptable) of that specific chemical's or chemical family's stability and that an appropriate "use by" or expiry date be determined.

For in-house prepared solutions, such as mobile phases or other non-quantitative solutions, FDA would expect that an assessment be conducted (again, literature review may be acceptable) to determine an appropriate expiry period. However, for in-house prepared solutions used for quantitative analysis, such as sample or standard solutions used in assay or impurity testing or titration solutions, FDA requires that formal stability studies be conducted to determine an appropriate expiry. As mentioned in Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology, the stability of analytical solutions is a typical method variation that should be evaluated during robustness testing during method validation. Method validation is a CGMP requirement at 211.160(b).

The determined "use by" or expiry dates should be documented within a procedure and followed. Procedures for any in-house prepared laboratory solution should include the determined stability timeframe, and should instruct that these solutions be labeled with the appropriately determined "use by" or expiration date upon preparation and discarded upon expiration.
 

moounir

Involved In Discussions
#6
Hi,

Interesting discussion. For what I understand, this "Best before date" will not be communicated to your customers. This is more a logistic date.

I used to have that in our logistic procedure to serve better our customer per counrty. It means that if a customer is ordering a product, we have to provide him one with a minimun shelf life of 6 months for this country and 3 months for that one.

If at the picking the shelf life is less than 6 months we keep it for another country.

The regulation just says that you should not use the product after the expiry date. So if you want you can sell a product with 5 days of shelf life and if your customer accept it, it's ok.

But I imagine that when you go to a grocery shop and look for milk, you'll not take the one with 1 reamaining day of shelf-life even if the product is still ok.

To conclude. You can have that in a document (linked to a procedure). This means that on your procedure for logistic you define that internally to serve your customers better you have a best before date per country. And you link to a document with all the best before date for each country.

Why per country?
Because if you are located in Italy, the logistic time to sell your product locally will be shorter than if you send them to China.

I hope this helps.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#7
My organization uses the same approach as moounir. Our Customers in some segments won’t purchase material that is too close it’s expiry date such they won’t use it all before it expires. We don’t publish this but we do use it in planning to control inventory, trigger new builds to maintain availability and try to minimize scrap.

I suspect that this is pretty common in many industries. . For example I won’t buy milk that is within 3-5 days of its expiry because I know I won’t use all of it before the expiry date. The phrase “best by date” is really a misnomer in this case, it is actually a guard-band for the expiry date to minimize scrap by the purchaser.
 

SpartanBio

Involved In Discussions
#8
:thanks:

Thanks all, you have given me some guidance on how I might be able to address this.

Yes the best before date is earlier than the expiry date. For those using the ship to area idea how do you find that works with such quick shipping? We ship our product on dry ice and the longest lead time is 4 days.
 

Candi1024

Quite Involved in Discussions
#9
My company makes a reagent that has an expiry date. That expiry date is on our labeling, in what we communicated to the reg bodies, etc. Internally we have a best before date. A date that after we hit that date we don't like to ship it to the customer. Our customers don't require this, we haven't communicated it to anyone (i.e. reg bodies). Now the powers that be want to include the best before date terminology in our documents. Give it as justification for scraping product that hasn't yet expired. I feel like this is not the right thing to do. Any thoughts.

Thanks
Keri
If you are doing something that is done to protect customer satisfaction, why wouldn't you document it?

Exactly what documents do they want to include this in? Internal procedures or something that would go to customers?
 

Edward Reesor

Trusted Information Resource
#10
RE: Use of Symbols

Since we have discussed the differences between "Best Before" and "Expiry" dates (and/or "Use before"), are there symbols that are suggested besides the half full (or half empty for those pessimists in the audience) hour glass?
 
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