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Comparing US/FDA Drug Regulations against US/FDA Device Regulations

Aaria

Involved In Discussions
#1
Is anyone aware of a matrix comparing US/FDA drugs regulations against US/FDA device regulations?

Please comment: is it required for a drug company to have a "quality manual?" This is standard practice in the device world but I cannot find any references to a requirement or suggestion to have one for drugs
 
#3
Both Drugs (21 CFR Parts 210 and 211) and Medical Devices (21 CFR Part 820) are for different areas and thus can not be compared. Likewise its the same for Food and Biologics.
Agreed that they both covering different areas, but with advent of QbD, QRM, new-Process validation guidelines, ICH Q10, etc., aren't these regulations getting closer and closer (& similar)to each other.?
 

Ajit Basrur

Staff member
Admin
#4
Agreed that they both covering different areas, but with advent of QbD, QRM, new-Process validation guidelines, ICH Q10, etc., aren't these regulations getting closer and closer (& similar)to each other.?
Of course, there are many common principles concerning GMP and related concepts but the OP wanted to have a matrix comparing drugs regulations against device regulations.
 
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