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Anonymous	10-31-05 05:14 AM - Post#3036 Hello everyone, We are manufacturers of OTC (finished) drugs. I want to know if someone knows of any regulations regarding 1. effect of a change in manufacturer of an API used to make finished good on stability study 2. effect of a change in mfgr of an excipient used to make finished good on stability study. I know or came acroos regulations on post-approval changes for API and other excipients (which states change in suppliers), but do these regs apply for OTC. Thanks you
Anonymous	10-31-05 06:49 AM - Post#3039 No way around it you must validate the alternate supplier if for no other reason than due dilligence. The rationale for this would be such- you know through empirical data (stability history for the OTC product in question) that it is stable in its first formulation, but how can you be certain that your product is stable in the 2nd generation (with new active)? The only way is to perform stability testing with the new formulation. Keep in mind that you could probably do accellerated to get you product into the market, while simultaneously doing Room Temperature to support product presence in the market during its shelf life. After a year of favorable Accellerated and Room Temperature data you have now validated the alternate supplier and so long as the vendor doesn't change their specifications you can then switch back and forth between the two products freely as you have data supporting this action. As far as regulations supporting this I have to assume that the cGMP's as they are currentyl written are sufficiently enforceable from a regulatory perspective regardless of whether OTC or Rx. IHN

Username

Post: Stability Testing

Anonymous

10-31-05 05:14 AM - Post#3036

Hello everyone,

We are manufacturers of OTC (finished) drugs. I want to know if someone knows of any regulations regarding
1. effect of a change in manufacturer of an API used to make finished good on stability study
2. effect of a change in mfgr of an excipient used to make finished good on stability study.

I know or came acroos regulations on post-approval changes for API and other excipients (which states change in suppliers), but do these regs apply for OTC.

Thanks you

Anonymous

10-31-05 06:49 AM - Post#3039

No way around it you must validate the alternate supplier if for no other reason than due dilligence.

The rationale for this would be such- you know through empirical data (stability history for the OTC product in question) that it is stable in its first formulation, but how can you be certain that your product is stable in the 2nd generation (with new active)? The only way is to perform stability testing with the new formulation.

Keep in mind that you could probably do accellerated to get you product into the market, while simultaneously doing Room Temperature to support product presence in the market during its shelf life.

After a year of favorable Accellerated and Room Temperature data you have now validated the alternate supplier and so long as the vendor doesn't change their specifications you can then switch back and forth between the two products freely as you have data supporting this action.

As far as regulations supporting this I have to assume that the cGMP's as they are currentyl written are sufficiently enforceable from a regulatory perspective regardless of whether OTC or Rx.

IHN

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