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Re: API Retesting (vs Shelf Life)
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Dear Steve, The following quote is from "GMP Interpretation Decision Records - 2003 Edition". which is an FDA Q&A. Q.5 An API can be used after the retest date assigned by the API fabricator if a re-analysis done immediately before use shows that it still meets its specifications. Can the new data generated be used by the drug fabricator to assign a longer retest date to future lots of this API obtained from the same fabricator? A.5 No. The extension of the retest date originally assigned to the API should be supported by data generated through a formal stability protocol. This may require the filing of a notifiable change submission. Please refer to the appropriate review Directorate. (September 9, 2003) My reading of this is that the API can be used if it is tested and is still in spec at the time of use....however you cannot extend the retest period based on that data [ICH interpretation of stability data explains why]. All jurisdictions are now recommending the use of the term retest rather than shelf life. So basically, without having reviewed any specific issues, I would say that you are perfectly OK in relying on retest in terms of regulations. In fact as you imply that this is probably for clinical studies, the regulations are even a little less restrictive. So from a regulatory compliance viewpoint, with all the normal reservations, I would say you are on a solid basis. However, there are scientific issues that should be taken into account and this assumes that your impurity'degradation limits are within ICH guidances as well. I could imagine that someone might set a very wide degradation/impurity specification and then argue that the product is "stable" at retest. This would obviously not be acceptable. Hope that helps, Regards Dr. Malcolm Ross Generapharm-Training and Consultancy Basel-Switzerland |
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