Dear Radwan,
As long as you formulate your API into your finished product by the assigned API retest/expiry date, dating of which is supported by the API stability data in your API stability program per ICH Q7, you should be fine. The drug product stability takes over, and the shelf-life of the drug product applies, after you formulate your API into the finished product.
For your example, you can formulate Ibuprofen into your product by June 2015 (not after!) and then apply the three year expiry date to the drug product. As long as you are formulating into product by June 2015, you are fine to proceed.
I have not heard of practice applying the API stability over the shelf-life of the product: I see that as an extreme misinterpretation of the requirements. The stability profile of the pure API can be significantly different from the formulated drug product. The data on the actual material supports stability of THAT material. API retest/expiry periods are based on API stability data, assuring that the material is good to use will the last day of shelf-life assigned. Drug product shelf-life is based on drug product stability data, assuring that drug product is good till last date of expiry period assigned.
Thank you and warm regards!
Jing
Jing Capucao, Ph. D.
R&D Stability Manager
McNeil Consumer Healthcare
[log in to unmask]
215-273-2441
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Radwan Almofti
Sent: Monday, March 23, 2015 4:36 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] About expiry date of APIs and expiry date of finished product
Importance: High
Hi Everyone,
Could you please let me know if I can use an API that will expire soon to manufacture a finished product with shelf life that will pass the expiry date of that API?
For example, if I want to use Ibuprofen that will expire in June 2015 to make the tablets or oral liquid or any other finished dosage forms that has the shelf life of 3 years which means that Ibuprofen will expire in the tablets (or other dosage forms) while they are being consumed.
Is that acceptable by GMP/CGMP, FDA and/or other regulatory bodies such as Health Canada or EMA?
Many thanks,
Radwan
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BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Hardy Diagnostics - http://www.HardyDiagnostics.com
Provides a complete selection of laboratory and microbiology supplies
for the clinical, industrial, and molecular biology research communities.
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