Could the term "GMP" be used in a Medical Device world?

SGquality

Quite Involved in Discussions
#1
Is it okay to use the term "GMP" in the Medical device world despite the word coming from Pharmaceuticals and the 21 CFR Parts 210/211 ?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Could the term "GMP" be used in a Medical Device world ?

For decades many people have called 21CFR 820, properly short-named the Quality System Regulations, the "GMPs".
 

Marcelo

Inactive Registered Visitor
#4
The original 21 CFR 820 from 1978 was called "21 CFR Part 820, Good Manufacturing Practice For Medical Devices".

The 1996 version, as mentioned by MIREGMGR, is called now "Quality System Regulations".

A rationale for this change can be found in the final rule preamble:

1. The title of the regulation, as reflected in this section, has
been changed from the ``Current Good Manufacturing Practices (CGMP)''
regulation to the ``Quality System'' regulation. This revision follows
the suggestion underlying many comments on specific provisions that FDA
generally harmonize the CGMP requirements and terminology with
international standards. ISO 9001:1994, ISO/CD 13485, and EN 46001
employ this terminology to describe the CGMP requirements. In addition,
this title accurately describes the sum of the requirements, which now
include the CGMP requirements for design, purchasing, and servicing
controls. CGMP requirements now cover a full quality system.
 
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