Generic Marketplace Risk Assessment

[mdenham]

In the context of Quality Risk Management, the GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) includes regulated organization and supplier considerations on quality risk management.

It states that "Suppliers should be willing to share their 'generic marketplace' risk assessment for a product, application, ..." (emphasis mine) (see page 26 of the guide).

My question is twofold:

1. Do you have a distinct "marketplace" risk assessment, and
2. If yes, in what way does it differ from the standard risk assessment?

Lastly, can you point me to an example?

 

[Tidge]

It has been ages since I reviewed that resource (or its precursor). My vague recollection was that the specific recommendation emphasized was a cautionary statement along the lines of: For a product destined for the marketplace, don't ignore checking/testing for attributes/characteristics that the market cares about, distinct from functional requirements. An example would be looking for cosmetic damage on a product that otherwise "works great", because people likely won't buy a product that looks like junk.

A general "marketplace assessment" prior to any early phase design control activities can certainly be rationalized, but personally I wouldn't formalize such a thing and I certainly wouldn't put it in the category of "GxP". Written another way, knowing that there is a place in the market for a given device (with some features, at some cost) is good for business, but something as simple as a SWOT analysis would be fine. I've certainly known companies that tried to put the device they wanted to make on the market only to discover the market didn't want that device. I don't think these were GxP failures, as in those case of those failures it was usually a combination of stubbornness or willful ignorance.