Source: http://mpomag.texterity.com/mpomag/june_2017?pg=41
Timestamp: 2019-07-23 19:58:42
Document Index: 498706436

Matched Legal Cases: ['arts 210', 'art 820', 'art 820', 'art 210', 'art 211', 'art 2', 'arts 210', 'art 820']

James A. Dunning • Owner, QPC Services LLC
I’m hoping to change that with this ongoing series assessing parts of both industries’ cGMP requirements. In the April issue of MPO, I provided a high-level comparison of sections of the pharmaceutical industry’s cGMP, Parts 210 and 2011, and the medical device sector’s cGMP Part 820. This column, however, will focus on how 21 CFR Part 820 Quality System Regulation, also known as the cGMP regulation for medical devices, aligns with the cGMP requirements of 21 CFR Part 210 and 21 CFR Part 211 Subpart A— General Provisions, with a Part 2 in an upcoming issue.
A general note: The term“pharmaceutical(s)” is used rather than“drug(s)” unless the term is part of an excerpt from the cGMP regulation.
Scope and applicability are adequately described in both the pharmaceutical and medical device cGMP regulations, specifically in sections 210.1 and 210.2 and in 211 Subpart A— General Provisions for pharmaceuticals; in section 211.1 Scope; and Subpart A—General Provisions for medical devices, specifically 820.1 Scope. Both regulations refer to other cGMP requirements for biologic products.
Definitions for pharmaceuticals are provided in 210.3 and ref-
erenced in 211 Subpart A—General Provisions, section 211.3
Definitions. Definitions for medical devices are provided in
820 Subpart A—General Provisions, section 820.3 Definitions.
There are terms used in both cGMP regulations that are not
listed in the respective definitions sections of the cGMP regula-
tions but my only focus is the elements of the definitions sec-
tions, and only those I believe to be key definitions. I grouped
the definitions in broad categories for easy comparison, and
stripped specific citations included in the cGMP regulations to
de-clutter the definitions. In most cases, but not all, I grouped
the definitions by their respective cGMP regulation. Definitions
are one component that should be used to set the foundation
for a company’s culture.
21 CFR Parts 210 and 211 Subpart A – General Provisions. 21 CFR Part 820 (as applicable)
1 210.1 Status of current good manufacturing practice regulations 820.1 Scope
2 210.2 Applicability of current good manufacturing practice regulations 820.1 Scope
3 210.3 Definitions 820.3 Definitions N/A 211 Subpart A – General Provisions 820 Subpart A – General Provisions
4 • 211.1 Scope 820.1 Scope
5 • 211.3 Definitions See Item #3