Thank you Shaban, " No " is not enough for me unless you have a scientific explanation  or justification because I have already mentioned that GMP says No, but if retested again & found to comply, why can't we use it ?

For yourself it's o.k. to use as medicinal agent to treat a malady, I do for myself, sometimes, whenever I feel that it's well stored, but I never advise others. I'm in the field, and can by the structure understand what may happen.

N.B. Some medicinal agents might not meet the pharmacopeia limits even before expiry, when not being well stored.

Please read the following:

http://articles.mercola.com/sites/articles/archive/2012/10/22/expired-drugs.aspx

http://www.emedexpert.com/tips/expired-meds.shtml

http://www.sciencebasedmedicine.org/the-drug-expiry-date-a-necessary-safety-measure-or-yet-another-big-pharma-conspiracy/

http://www.scientificamerican.healthafter50.com/alerts/prescription_drugs/JohnsHopkinsPrescriptionDrugsHealthAlert_677-1.html

Dears,

Thank you for your interest, may be the question was not well understood , I do not mean using expired pharmaceutical products, nor expired active ingredients without testing. I mean expired active ingredients that are fully tested and found to be within limits including tests for degradation products, related substances, optical rotation, FTIR, etc. to confirm stability. 

For your information, some expired API have been tested and found to comply ! 

So, for the three fears mentioned by Mr. Ahsan:

I don't agree with you, as the reduction in activity and the toxic metabolites can be easily detected by the full analysis , as the pharmacopeial monograph is definitely based on physics-chemical  and stability study of the API.

can we extrapolate the shelf life of API beyond that stated on the label if retested and found unchanged ? Why ?

Best regards

Regarding your second question and as a pharmacist, yes, but

1- You have to start all of the investigations for the raw material as if it's just synthesized or imported, and you need to apply all of the pharmacopeal investigations needed for a compound that is just introduced by this new character. If it fulfills and passes the limit tests, it has to be refiled again by its new data.

2- This have not to be followed for reference compounds in your lab. In such a case the old reference have to be treated as a raw material against a new reference. 

Yes you can.

However a retest is needed and "new expiring date" will be determined by the forced degradation studies of your API.

All is in ICH guidelines Q7 section 11.6

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/08/WC500191492.pdf

This question has been addressed in Q7 Q&A in section 14.2.

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/ICH_Q7-IWG_QA_v5_0_14Apr2015_FINAL_for_publication_17June2015.pdf

"According to the definition, material should not be used after the expiry date. The original intent of this definition in ICH Q7 was that expired API should not be used in drug product formulation. It may be acceptable to reprocess [ICH Q7, Section 14.2] or rework [ICH Q7, Section 14.3] the expired API where the API manufacturer has all related historical GMP documentation and additional stability data on the reworked or reprocessed API. There may be registration/filing considerations that are beyond the scope of ICH Q7 in addition to the GMP considerations."

The question is less clear if the API has a re-test date instead of an expiry date. Some interpret guidance in a way that would allow for use in formulation after a retest date if the retest data conforms and the API is used immediately. This is based on Q1A and Q7 definition of Re-test Date in the Glossary section. There is an "expiry" vs "re-test" disconnect that can be confusing. I assume because the term "expiry" may imply there is a known quality attribute that is at risk beyond the timeframe supported by stability data, whereas "re-test" indicates no known quality risk but no supporting data? Q7 section 11.61 states that common practice is to use a retest date, not an expiration date for API's.

If you can not use an expired API after "retest" but the only way is to reprocess or rework it, why GMP use "retest" for API? You actually don't need to retest it because you can not use it after retest date. Why bother? It's confusing.

The confusion might be due to the term "expiry" being used instead of "retest" They are not the same thing. If the API CoA gives a retest date, then it can be used after retesting (appropriate supporting stability data should be obtained). If the CoA gives an expiry date, then it should not be used per Q7 definition of the term "expiry" as clarified in the Q&A. The issue is "expiry" is sometimes mistakenly used instead of "retest" on API's. Q7 section 11.61 indicates that for API, "Common practice is to use a retest date, not an expiration date." Expiry indicates there is a known timeframe past which the quality of the DS or DP can no longer be assured. For example, stability data shows degradation past a certain time point. Or sometime the term expiry is used when there is no intention of extending the stability study to support a longer time point.

Dear All,

My questions is "My API expiry is 2 years but the batch which I have manufactured is expiry 5 years" will it be acceptable for export or not. if yes can we have the guideline for the same.