Define the operation unit dosing

Reference no: EM133345768

Question 1: Define the operation "unit dosing"

Question 2: List and explain two (2) Operating Principles of Part I and explain how subclasses are distinguished for those operating principles

Question 3: Scenario: Company A wants to switch from a 10 cu.ft Bin Blender to a 20 cu.ft Bin Blender for an IR product due to scale up. What type of submission does this change require? (Note: Refer to Changes of an Approved NDA/ANDA Guidance and/or SUPAC-IR).

Question 4: Is there a stability requirement? If yes, identify condition(s) and when the stability is reported to the Agency.

Reference no: EM133345768

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