Questions on Risk-Based CMC Review

1
Questions onRisk-Based CMC Review

• Advisory Committee for Pharmaceutical Science
• July 19-20, 2001
• Yuan-yuan Chiu, Ph.D.
• Co-chair, CMCCC
• CDER, FDA

2
Question 1 to the ACPS

• Is the approach of establishing attributes and
  acceptance criteria for drug substance, drug
  product and microbiology based also on the
  characteristics of potential candidates of low
  risk drugs appropriate?

3
Question 2 to the AC

• Is it appropriate to evaluate not only a firms
  general CGMP status but also its manufacturing
  history of a specific product on the low risk
  drug list? (If the answer is yes, there will be
  no TANDA)