Welcome to the 24th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode is focusing on quality risk management — the process for systematically identifying, assessing, and controlling risk to the quality of pharmaceutical products across the product lifecycle. Although the Automating Quality Podcast talks about risk quite often, this episode will be specifically zoning in on the concept of quality risk management (or QRM), how it is implemented, the four key phases that define the QRM lifecycle, and many other important additional elements. Mandy Gervasio will be breaking down this topic in today’s solo’s episode, highlighting the most foundational key elements of QRM!
Listeners that are new to the industry and veterans alike will get plenty of value from today’s episode. So be sure to tune in to brush up on the fundamentals of leveraging a QRM methodology!
[:30] About today’s episode.
[1:35] What is QRM? And where is this methodology most often leveraged?
[4:23] How is QRM implemented? And what are some key benefits?
[5:26] How ICH Q9 has impacted the pharma industry, as well as transformed past precedences.
[10:40] Mandy outlines the four key phases that define the QRM lifecycle.
[14:31] Mandy highlights an important element to the QRM lifecycle: risk communication.
[16:02] How ICH Q9 has been the catalyst for a significant paradigm shift in traditional GMP processes and benchmark standards.
[20:05] Mandy wraps up the episode by summarizing what QRM is.
[20:43] What to look forward to in future episodes!
[21:09] Mandy thanks you all for tuning in for this week’s episode. If you want to get in touch with her, you can contact her at Mandy.Podcast@Solabs.com.
Mentioned in this Episode:
Quality Risk Management (QRM)
Quality by Design (QBD)