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good quality of product, and we'll be working on doing that as part of this initiative.

Also, I think we talked briefly yesterday, Ajaz talked briefly about the PAT initiative, the process analytical technologies, and this is part of the manufacturing science part of the GMP initiative.

I think, too, this is one part that we will see continuously with this advisory committee.  We'll bring a number of questions, I think, at least to the Manufacturing Subcommittee and then on to the advisory committee.

Changes without prior review.  We talked about this yesterday on comparability protocols.  This is to identify opportunities to allow postapproval manufacturing changes without FDA review and approval prior to implementation.

Risk management work planning.  This is an area that we feel like we need to spend efforts on in the agency.  We need to have a better way of ensuring systematic risk management approaches throughout.  We need to implement risk-based approaches that focus both industry and FDA's attention on the critical areas which

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