Chemical Engineering March 2014 - 52

ous FDA-regulated industries, we
can use it as an example of how the
FDA inspection guides can be utilized
by the engineer. For this we
will refer to the FDA's " Guide to Inspections
of High-Purity Water Systems " ,
which can be found at www.
fda.gov/iceci/inspections/inspectionguides/ucm074905.htm
This
guide includes the following
chapters:
I.
System design
II. System validation
III. Microbial limits
IV. Water for injection systems
V. Stills
VI. Heat exchangers
VII. Holding tank
VIII. Pumps
IX. Piping
X.
Reverse osmosis
XI. Purified water systems
XII. Process water (numbered as
XIII on website)
XIII. Inspection strategy (numbered
as XIV on website)
An example of what can be
learned from an inspection guideline
is represented in the following
paragraph quoted from Paragraph
II " System Validation. " In it, the
third paragraph states:
" In the review of a validation
report, or in the validation of a
high-purity water system, there
are several aspects that should be
considered. Documentation should
include a description of the system
along with a print. The drawing
needs to show all equipment in the
system from the water feed to points
of use. It should also show all sampling
points and their designations.
If a system has no print, it is usually
considered an objectionable
condition. The thinking is if there is
no print, then how can the system be
validated? How can a quality control
manager or microbiologist know
where to sample? In those facilities
observed without updated prints,
serious problems were identified in
these systems. The print should be
compared to the actual system annually
to insure its accuracy, to detect
unreported changes and confirm
reported changes to the system. "
There are seven key take-aways
from the " System Validation " paraFinal
remarks
While there is so much more to
be said with regard to the FDA's
Form 483, and the Warning Letter
for that matter, an essential point
is that the FDA inspection process
should not be treated like a thorn
in the side. It should instead be
treated as if you were working with
a third-party inspector, an inspector
with a little more force behind
his or her decisions.
The key factor in all this is arguably
the rules of engagement. As
long as an owner or engineer understands
the rules that the FDA inspector
is playing by, an acceptable
inspection result is certainly attainable.
An acceptable inspection result
is considered here to be one in which
the inspection report would result in
zero Form 483s or even one with a
few minor Form 483s.
The basic disconnect lies in what
the FDA inspector expects to see
and how the owner or engineer
plans to meet that expectation. In
order to meet at that crossroads, the
owner or engineer should preemptively
develop a set of design and
engineering specifications based on
what can be gleaned from the three
sources mentioned throughout this
discussion. This would include, as
represented in Figure 2: Proper
CFRs, FDA inspector training
guides, and industry standards.
Looking at the FDA inspector as
graph that includes the need for:
1. Preparation of a validation report
2. Written description of the piping
system
3. A representative isometric drawing
of the system
4. Drawings that show all
equipment
5. Drawings that show identified
sampling points
6. Point of use locations (with
identifiers)
7. A quality management system
that should include a process by
which there is a requirement to
walk down each system on a periodic
basis at intervals that do
not exceed a twelve month period
in order to verify the system's asinstalled
condition
a third-party inspector, rather than
as a law-enforcement official, will
help a company understand him or
her more as a beneficial asset and
less as a hindrance. Unless a company
is subversively attempting to
circumvent regulations by skipping
steps in the regulatory process, or
is simply trying to keep cost down
at the risk of food or drug adulteration,
then an audit, however painful
it might seem at the outset, should
be looked upon as an incremental,
beneficial, and integral part of the
design, engineering, construction
and commissioning process.
From a very fundamental perspective,
we should all be designing
and building facilities that manufacture
product intended for human
consumption and cosmetic application
in a manner that will produce
a product that is inherently safe in
a consistent and verifiable manner
with an overreaching consideration
toward public health. The job of the
FDA inspector is to verify that we
are doing just that.
■
Edited by Gerald Ondrey
References
1. ASME-BPE Standard, www.asme.org/groups(1)/technical-institutes-and-divisions/bioprocessing-equipment
2.
International Society of Pharmaceutical Engineers
(ISPE), www.ispe.org.
3. 3-A Sanitary Standards, Inc. (3-A SSI),
www.3-a.org.
Author
W. M. (Bill) Huitt has been
involved in industrial piping
design, engineering and
construction since 1965. His
positions have included design
engineer, piping design
instructor, project engineer,
project supervisor, piping
department supervisor,
engineering manager and
president of W. M. Huitt Co.
(P.O. Box 31154, St. Louis,
MO 63131-0154; Phone: 314-966-8919; Email:
wmhuitt@aol.com), a piping consulting firm
founded in 1987. His experience covers both the
engineering and construction fields and crosses
industry lines to include petroleum refining,
chemical, petrochemical, pharmaceutical, pulpand-paper,
nuclear power, biofuel and coal gasification.
He has written numerous specifications,
guidelines, papers and magazine articles on the
topic of pipe design and engineering. Huitt is a
member of ISPE (International Society of Pharmaceutical
Engineers), CSI (Construction Specifications
Institute) and ASME (American Society
of Mechanical Engineers). He is a member of the
B31.3 committee, a member of three ASME-BPE
subcommittees and several Task Groups, ASME
Board on Conformity Assessment for BPE Certification
where he serves as vice chair, a member
of the API (American Petroleum Institute) Task
Group for RP-2611, serves on two corporate specification
review boards, and was on the Advisory
Board for ChemInnovations 2010 and 2011, a
multi-industry conference & exposition.
ChemiCal engineering www.Che.Com marCh 2014 53

http://www.fda.gov/iceci/inspections/inspection http://www.asme.org/groups http://www.ispe.org http://www.3-a.org http://www.Che.Com

Chemical Engineering March 2014

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