Need suggestions: Risk Analysis for Pharma

Question

We're putting together a demo for a pharma company (non-JMP users, trying to sell to them).  It was suggested that we use the same agenda as Erich Gundlach had used in the past, specifically:

Introduction to JMP in Pharmaceuticals

Topic Include:

Stability studies for new product launches

DOE

Root Cause Analysis

Control Studies

Risk Analysis

Homogeneity

So far I haven't found any of Erich's old materials, so I'll be creating my own journal.  I've got a handle on all topics except for "Risk Analysis".

Does anyone have an idea of what Erich might have been doing with Risk Analysis (specifically related to Pharma)??

Thanks!

Byron_JMP · Answer

Perhaps Erich was using the profiler's simulator, with specs added for the responses. In this case you can show the risk(probability) of being out of spec given a factor setting and its expected variation.

Since Risk is right after control charts, its also likey that he was covering process capability, and using low Ppk as an index for risk.

martindemel · Answer

Hi Jerry,

not sure what Eric did, but this might be a good reference what is meant by risk analysis/risk assessment in pharma:

https://learnaboutgmp.com/good-manufacturing-practices-cgmp/quality-risk-management-within-the-pharmaceutical-industry/

In general what youz show in your agenda before this topic is almost all part of this risk analysis approach. ICH you capture in stability analysis (as well analysis based on Hazard), root cause you cover as well as DOE which can be added to root cause or treated seperately in optimization and for robustness studies (this might be a missing topic in your list if not included unter the main topics).

Last but not least they need to monitor the threats coming in when the product is already in the market. Where they have to constistently check the quality using trend charts, listen to the VoC and Voice of medical centers profiding new feedback on the adverse events which might come up newly.

Guess others have additional thoughts on it, but that's what I would relate it too.