Does 820.30 include the manufacturing process?

Watchcat

Trusted Information Resource
#1
I'm reacting to a claim that 820.30 "fundamentally and specifically demands that the responsible organization not only design the product, but also the manufacturing process."

There are really several claims here, all of which are news to me:

1. That 820.30 dictates who has to do the design work.
2. That it requires that the same organization that designed the product also design the manufacturing process. (Do you design a manufacturing process?)
3. That it is applicable to the manufacturing process.

All of this is outside my own scope of expertise. Nonetheless, I was very surprised to hear this, and wondered if some of the Covers who are experienced in this area could shed some light.
 
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William55401

Involved In Discussions
#2
The manufacturing process owner / designer can be a separate entity from Design Authority. 820.30 (h) is Design Transfer and this QSR element ensures that design is translated into Production Specifications. There is a large world of Contract Manufacturing Organizations that take designs from customers and build the product. These CMOs develop the production specifications. The organization that places the product on the market (the legal manufacturer) is responsible for oversight on the CMO. The FDA establishment registration and listing website has Contract Manufacturer as an option you can search on.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
1. That 820.30 dictates who has to do the design work.
When part 820 talks of the manufacturer's obligations it refers to responsibility, not to who actually does the work. The regulatory owner of record (AKA the "legal manufacturer") is responsible for design work and also (formally) for manufacturing. There are, however, precedents where a CM was held responsible - it can happen when the CM holds all the expertise and the (design) Specification Developer holds none or close to none. But like you pointed out in another thread FDA is not a monolith and also evolves over time, so I can't tell how relevant it is today.
2. That it requires that the same organization that designed the product also design the manufacturing process.
Not in the sense of actually doing the work. Yes in the responsibility sense.
(Do you design a manufacturing process?)
Yes.
3. That it is applicable to the manufacturing process.
Only in so far as it relates to developing the necessary, adequate manufacturing processes.
 
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