Hi Michael,
Nothing in the GMP regulations (21 CFR Parts 210 and 211) directly states
that the quality control department or quality control personnel may not
report to production personnel. However, the GMP regulations do set
responsibilities for the QC unit and/or QC personnel that might imply a
conflict of interest when such personnel report to the production
department.
The only place that I've found anything in writing on the subject from FDA
is in Docket No. 91N-0450, CBER's "Guideline for Quality Assurance in Blood
Establishments, dated July 11, 1995
(http://www.fda.gov/CBER/gdlns/gde_qa.pdf). The first sentence in the third
paragraph under the subheading "Reporting Responsibilities," following the
heading "QUALITY ASSURANCE FUNCTION," FDA says "The QC/QA Unit reports
independently from production to management.
I realize that this reference is from CBER, not CDER, but I've known for
years that this issue was not discussed in 21 CFR Parts 210 and 211. I am
not aware of this being required by the federal Food, Drug, and Cosmetic Act
or any other law or regulation enforced by FDA. I assumed that FDA included
a discussion of this issue in their "GMP notes," a guidance, a trade
correspondence, or some other written communication.
I've been working in the drug industry since 1969 and have been aware of
this "requirement" pretty much since I started, but have never seen anything
in writing from FDA until I found the reference from CBER today.
Maybe someone else can find something a little more concrete.
Rick Flora
President/General Partner
R. FLORA & ASSOCIATES
Email: rflora@rflora.com
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