I recently met with a client that wants to simplify their master recipe to align with the manufacturing steps outlined in their filing. The thought is to keep the "what to do" in the recipe and move all the "hows" to the SOPs. Process data not collected in the batch record would be historized at the site level. Using this method the belief is that a single recipe could be used across sites and the time for release reduced.
What are the challenges to this approach?
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