2.3.R REGIONAL INFORMATION 2.3.R.1 Production Documentation 2.3.R.1.1 Executed Production Documents (a) List of batches (including strengths) for which executed production documents have been provided (e.g. comparative bioavailability or biowaiver batches): 2.3.R.1.2 Master Production Documents (a) The blank master production documents for each strength, proposed commercial batch Module 3. size and manufacturing facility should be provided in Discussion of differences between the proposed commercial batch size master production documents compared to the biostudy batch records with respect to the formulation (2.3.P.2.2.1 b) (ii)) and the manufacturing process (2.3.P.2.3 b)): <include a tabulated discussion for all differences, including processes, equipment (model/make/capacity), settings and operating parameters > Proposed production Bioequivalence/biowaiver Parameter (e.g. Discussion of the batches batch process, equipment, relevance of the <indicate proposed batch process parameter) differences <indicate batch number> size> <Main processes and associated equipment (make, model, capacity, settings)>
2.3.R REGIONAL INFORMATION 2.3.R.1 Production Documentation 2.3.R.1.1 Executed Production Documents (a) List of batches (including strengths) for which executed production documents have been provided (e.g. comparative bioavailability or biowaiver batches): 2.3.R.1.2 Master Production Documents (a) The blank master production documents for each strength, proposed commercial batch size and manufacturing facility should be provided in Module 3. Discussion of differences between the proposed commercial batch size master production documents compared to the biostudy batch records with respect to the formulation (2.3.P.2.2.1 b) (ii)) and the manufacturing process (2.3.P.2.3 b)): <include a tabulated discussion for all differences, including processes, equipment (model/make/capacity), settings and operating parameters > Parameter (e.g. process, equipment, process parameter) Bioequivalence/biowaiver batch <indicate batch number> Proposed production batches <indicate proposed batch size> Discussion of the relevance of the differences <Main processes and associated equipment (make, model, capacity, settings)>
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