MPO - June 2017

REGULATORY PERSPECTIVES
Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

James A. Dunning • Owner, QPC Services LLC

Since they are both part of the healthcare industry, you’d think pharmaceutical and medical device companies would have a better understanding of each other’s current Good Manufacturing Practices (cGMP) requirements. Think again. Despite the obvious overlap between the sectors, drug and device firms just can’t seem to fully fathom any cGMP mandates but their own.

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

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

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.

Act

Pharmaceuticals—210.3 Definitions and Medical devices—820.3 Definitions:

The definition of act in both cGMP regulations refers to the Food, Drug and Cosmetic Act, as amended. The cGMP requirements for both pharmaceuticals and medical devices are derived from the Act.

Audit

Pharmaceuticals—210.3 Definitions

No definition included.

Medical devices—820.3 Definitions

“Quality audit means a systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.”

Comments: Key components to this definition are “systematic” and “independent.” This is especially relevant to smaller medical device manufacturers that cannot achieve an independent audit using internal personnel. Audits are not included in the pharmaceutical cGMPs, but in my experience, they certainly are performed as a matter of practice.