I’m here at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Hot on the agenda is quality. Quality by design, quality via process validation, quality via life cycle production. Nick Cappuccino presented the first session of the morning on ICH Q8, 9, and 10 implementation. Dr. Cappuccino is a member of the ICH Quality Implementation Group.
The quality trio guidances aren’t meant to teach industry about quality, said Dr. Cappuccino, industry has been manufacturing quality products for years. The guidances are meant to help industry address quality issues. Quality isn’t supposed to be “tested,” it’s supposed to “built in,” explained Dr. Cappuccino, who provided the following example of a traditional quality approach compared with today’s enhanced approach.
A traditional product approach might include these steps:
- Gain market input
- Develop API
- Develop process
- Implement finished product control, including submitting any changes via a regulatory supplement.
The enhanced approach, discussed in ICH Q8, 9, and 10, proposes these steps instead:
- Create a target product profile
- Conduct a risk assessment
- Complete API studies as well as formulation studies (this is where design space enters the process)
- Conduct process studies and develop a control strategy
- Control process
- Real-time release
- Note that any changes or improvements within the design space do not require regulatory supplement filings.
The overall benefit of compiling more information in the beginning and understanding more about the process is that manufacturers have more flexibility and less regulatory oversight, said Dr. Cappuccino.
Additional quality sessions are being held later today and tomorrow at the PharmTech conference. Stay tuned for more blog posts. And also stay tuned, says Dr. Cappuccino, for potential ICH guidance revisions. Being considered by the steering committee are changes to Q3A/B and Q6A/B in light of Q8, 9, and 10. Also coming soon from ICH are a third group of Q&As that address the quality trio guidances. Two groups of Q&As are already on the site at www.ich.org.