March 2017


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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Thu, 23 Mar 2017 09:06:35 -0400
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Filing an NDA using pilot scale API batches is ok as long as the process, specs etc are similar to the batches used in pivotal registration clinical batches. The problem is, once the NDA is approved and you want to use the commercial scale batches from a new site one would require an sNDA prior to using these batches. Unless, the pilot scale batch sizes from the pilot site approved as part of NDA are sufficient for your initial launch to the market (I.e. Rare or orphan indications) until your new commercial site is approved for bigger scale batches for later launches via sNDA.If you do follow the above strategy, please ensure that your pilot site is ready for a PAI (pre-approval inspection).
Your second option/strategy, I think you are trying to show equivalent in the proposed NDA by including one pilot batch from the pilot site and two commercial size lots from the new site? If so, not a bad idea but get an ok from the FDA via preNDA CMC meeting or some other interaction!Best,GRSAONLINE. ComGlobal Regulatory Strategic Advisors

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On Wednesday, March 22, 2017, 2:13 PM, Mazzeo (R&D), Tony <[log in to unmask]> wrote:

Hello stabilitarians,

I am not sure my last message got through so I am sending it again to see if I can get a response.

Does anyone have any experience with filing an NDA using pilot scale drug substance batches (primary stability batches) that were manufactured at a site that was not the commercial manufacturing site. Or having one of the three primary batches from a manufacturing site that was not the commercial site?

If, so, did you run into any issues with the ICH country reviewers or non-ICH reviewers?

I would appreciate hearing about your experiences.


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