Why did you extend the shelf life of the raw material? Was your retesting appropriate (did you perform Assay, Related Substances, Moisture…)? Do you have an SOP on retesting and shelf life extension? Does this SOP state how many times you can retest and extend shelf life?
The reason why I am asking all these questions is the answer is ‘it depends’! Some molecules degrade on exposure to air (oxidize) while other molecules are very stable (even when exposed to a nuclear explosion).
“the extended shelf life” i mean is the shelf life duration of the drug product. I dont mean to extend the raw material shelf life.
But it is indirectly let the raw materials stay few years longer when it is manufactured as a drug product, right?
So both raw materials and the drug product should be starting a new stability monitoring, right?
Esp. the stabiliy of the expring raw material after its expiry date.
Yes, i want to dig about the PICs requirement for this case. But it is so general, lol.
Thus, you must have an SOP that extends the shelf life. I would state;
No extensions for drug substance APIs (active pharmaceutical ingredients) since the manufacturer has the stability data and is not comfortable with extending the shelf life. See ICH Q6A. (As a former QC manager I would call sales and marketing into my office and ask why they are not doing their job)!
Excipients can have an extended shelf life (twice only) if they meet monograph requirements.
Dyes can be extended indefinitely if they meet FCC criteria and are still ‘free flowing’ (and not hard as concrete).
I realise the frustrations that both production and production scheduling may have (nothing quite like a lot you were expecting to use now in QC inspect status and thus not available). That is the reason why I knew what was in the warehouse and I gave production scheduling a monthly list of lots coming up for extensions or rejection. The software (we used 4th Shift) used by warehousing and production was able to make this list.
I have been looking for references on the acceptability of extending shelf life of excipients used in OTC and Prescriptions. You mentioned it can be extended. May I know what was the reference you used to come to this conclusion?
The raw materials expiration dating is given by the manufacturer of the raw material. They have stability studies showing how long their product is viable on the shelf. I believe, but have never done this - that you would probably have to do your own internal stability studies on the manufacture’s product in order to extend the dates.
You would have to make a business case for this. Is it worth doing your own internal stability study (on multiple lots for 6-12+ months)? It might be for a really expensive product (but these are excipients aren’t they, which are likely pretty cheap). At the last company I was at stability studies were $30-50k to run in lab time and materials.
Also, I think an auditor would really speculate and scrutinize that study. It could easily appear that business needs (using expired product) was more important that quality (staying within the recommended dates).
I personally wouldn’t try to extend the expiry date of some raw materials excipients used in your product.
You might call up the manufacturer and discuss this with them.
Alternatively, can you hurry up and make the tablet which has a 2-3 year shelf life? After it is manufacturered, you will have to store the product in your warehouse until there is market demand. You might end up selling at least some of the product before the 2-3 year shelf life expires.
But i need to clarify that we did not extend any raw materials expiry date, at least directly.
I think it is common in the industry.
For example, you have some Paracetamol raw material going to be expired in 01.01.2017.
Then the production department used it to make some tablets (which 95% Paracetamol + 2-5% starch, talc ,etc excipients, commonly) with shlef life around 3 years, e.g. 01.08.2019 expiry date.
Do you think it is really OK?? Though we all know it is very likely still safe in consumption in most cases, and legally OK.
But how about the standpoint at PICs/GMP? I wish to know that.
I’m not in the stability or expiry date industry. But I think it is pretty common to watch the expiry date of the raw materials, and to make the product prior to raw material expiration. And that the finished product expiry date will be based on the stability testing of the finished product.
You might have to discuss this with a stability expert (which I am not).
I can/t recommend to use your API which is approaching to Expiry in manufacturing of Formulations. In your case the AP will be expired after 6 months from the date of manufacturing which was assigned by API manufacturer and if you use that API surely your formulate product would be failed after 6 months. IF API manufacturer have recommended Retest date that means it can be used but not the beyond of the permitted extrapolation as per ICH Q1E and also you shall have your own stability data with that especially formulations manufactured with that API manufacturer only. but it doesn’t work since the Shelf life would be decided based on the API for formulation product.
This API will not change molecular change in your final product hence possibilities are more to degrade the product after expiry date in your Final Formulative product.
But if an Intermediate which can be used for API manufacturing can be used after ensure the quality of the Starting material (i,e Intermediate) since the Intermediate further will undergo to change the fragmentation of molecular.
Thats why formulation manufacturer used purchase the APIs which are manufactured freshly or below the 6 months.