Guidance for Industry Q10 Pharmaceutical Quality System

Senior Management:  Person(s) who direct and control a company or site at the highest levels 
with the authority and responsibility to mobilize resources within the company or site. (ICH Q10 
based in part on ISO 9000:2005) 
16

---

State of Control: A condition in which the set of controls consistently provides assurance of 
continued process performance and product quality. (ICH Q10) 
17

---

Annex I: Potential Opportunities To Enhance Science- and Risk-Based 
Regulatory Approaches *
*Note: This annex reflects potential opportunities to enhance regulatory approaches. The actual 
regulatory process will be determined by region. 
Scenario 
Potential Opportunity 
1. Comply with GMPs
Compliance – status quo
2. Demonstrate effective 
Opportunity to: 
pharmaceutical quality system, 
• increase use of risk-based 
including effective use of quality 
approaches for regulatory 
risk management principles (e.g., 
inspections 
ICH Q9 and ICH Q10).
3. Demonstrate product and process 
understanding, including effective 
use of quality risk management 
principles (e.g., ICH Q8 and ICH 
Q9). 
Opportunity to: 
• facilitate science-based 
pharmaceutical quality assessment
• enable innovative approaches to 
process validation 
• establish real-time release 
mechanisms 
4. Demonstrate effective 
pharmaceutical quality system and 
product and process understanding, 
including the use of quality risk 
management principles (e.g., ICH 
Q8, ICH Q9, and ICH Q10). 
Opportunity to: 
• increase use of risk-based 
approaches for regulatory 
inspections; 
• facilitate science-based 
pharmaceutical quality assessment;
• optimize science- and risk-based 
postapproval change processes to 
maximize benefits from innovation 
and continual improvement;
• enable innovative approaches to 
process validation; 
• establish real-time release 
mechanisms.
18

---