Mike,
This is an issue I've run across with very small organizations. In
the US, 21 CFR 211.22 only defines the responsibilities and authority
of the QC unit, not whom they should report to. I believe most of us
would agree that there should be separation between Quality and
Production functions. However, there are always regulatory
exceptions. An example is the following excerpt from FDA's draft
Guidance on PET Drug Products - Current Good Manufacturing Practice.
(<http://www.fda.gov/cder/guidance/5425dft2.htm>http://www.fda.gov/cder/guidance/5425dft2.htm):
B. Organization and Staffing
We recommend that staffing levels correspond to the size and
complexity of the operation of the PET production facility and enable
a PET production facility to satisfactorily complete all intended
tasks in a timely manner before administration of a finished PET drug
to humans. We recommend that the responsibilities and assigned duties
of all staff be clearly identified in written policies.
For a PET production facility that typically produces one or two
batches of a product daily, it may be adequate to employ one or two
persons to accomplish all production and quality control functions.
We recommend the PET facility demonstrate that the production and
quality control functions can be consistently accomplished in a
timely and appropriate manner before administration of a drug to
humans. One individual can be designated to perform the production as
well as quality control functions, provided he or she is highly
qualified in the performance of all such functions (i.e., has a
degree, documented training, and significant experience in the
technical area).
Under current CGMP regulations in 21 CFR Part 211, FDA normally
requires second-person checks at various stages of production as well
as test verification. In a PET production facility with only one
person assigned to perform production and quality control tasks, it
is recommended that that person recheck his or her own work.
Self-checks involve the confirmation of the operator's own action and
would be documented. Examples of self-check activities include
reviewing batch records (e.g., review the batch record to ensure that
all finished-product test results are within the acceptance criteria)
before release of the drug product for distribution and verifying
calculations in analytical tests.
At a PET production facility that produces multiple PET drugs, we
recommend the staffing level be adequate to perform all quality
assurance functions and to prevent mix-ups and cross contamination.
Hope this helps. Happy New Year,
Tom Mullins
Mullins Consulting
tjmullins@aol.com
|