2. Q4B OUTCOME

2.1.1 Instrument calibration and system suitability measurements should follow regional good manufacturing practice ( GMP ) requirements .Except for nominal 100-milliliter ( mL ) parentera products , the acceptance criteria are interchangeable .At the 100-mL nominal volume , the criteria specified in JP are more stringent than those in the other two pharmacopoeias .Therefore the criteria are not interchangeable in all three regions at that volume .