What exactly is ‘phase-appropriate’ quality?
In episode 4 of Let’s Talk Quality, I was joined by Amnon Eylath to discuss the origins of the well known term, ‘phase-appropriate’ quality. Amnon and I discuss the following:
- What exactly is ‘phase-appropriate’ quality?
- The history of GxP and how the term originated
- How the FDA guidance has evolved, and how it started
- Amon’s role in liaising with the FDA to develop a ‘graded approach’ to quality
- How this approach evolved into the term ‘phase-appropriate’
- What factors to consider when implementing quality that is ‘phase-appropriate’
- Real-life examples where this impacted the commercialisation of therapies
- Managing upwards with C-suite to promote quality within an organization
- The importance of understanding the science and technology
- What inspires Amnon to progress and contribute to society
This is a fascinating discussion about such a widely used phrase in quality assurance and the wider pharma and biotech industry.
Amnon’s knowledge on this subject matter dates back to before the term was coined and it’s fascinating to speak to someone who played a significant role in identifying the importance of implementing quality at the right time and to the right extent.
Hope you enjoy the show!