Chemical Engineering March 2014 - 49

Engineering Practice
CFR's
Industry
standards
or manufacturer are two sources to
help meet FDA compliance. But before
touching on these two very important
sources, let us take a look
at what is currently happening in
this industry.
In referring back to Table 2 you
can readily see that with 2,496 Form
483s issued in 2009, the " foods " category
has, by far, the greatest number
written against it; three times
that of the second runner-up, devices
with 817 infractions. Of that
2,496, an outstanding 61% were related
to sanitary issues.
These sanitary issues include
such incidents as rodent and insect
infestations, improper or infrequent
cleaning of equipment, and other
sanitary issues having to do with
waste, product storage, facility design
and so on. This is an example
of subjective calls made by the inspector
regarding conditions that
cannot be defined in simple blackand-white
terms.
Such conditions are assessed
based in large part upon what is contained
in the broad set of parameters
described in very general terms
in Title 21 Chapter I Subchapter B
Part 110 Subpart A Section 110.5 in
which it states, in part:
" 110.5 Current good manufacturing
practice. The criteria and
definitions in this part shall apply
in determining whether a food is
adulterated (1) within the meaning
of section 402(a)(3) of the act in that
the food has been manufactured
under such conditions that it is unfit
for food; or (2) within the meaning
of section 402(a)(4) of the act in that
the food has been prepared, packed,
or held under insanitary conditions
whereby it may have become contaminated
with filth, or whereby it
may have been rendered injurious
to health... "
What occurs in many cases,
whether it is food or drug products,
is that the manufacturer or engineer
interprets the finer points of
an industry law or regulation in
one way while the inspector interprets
it in another. The following
are cases-in-point:
* An issue cited 51 times during the
fiscal year 10/1/2009 to 9/30/2010
Design
specs
FDA
training
process descriptions, cleaning procedures,
weld logs and material certification
documents and more.
If metallic material, such as tubconcerned
equipment used in the
manufacture, processing, packing
or holding of drug products that
was not of appropriate design, of
adequate size, or suitably located to
facilitate operations for its intended
use, cleaning, or maintenance
* In that same time period, there
were 61 cited incidents in which
equipment and utensils were not
cleaned, maintained and sanitized
in an appropriate manner or at
appropriate intervals to prevent
malfunctions and contamination
that could alter the safety, identity,
strength, quality or purity of
the drug product
* In addition to the two different
types of incidents above, there
were many other incidents that
are too numerous to mention here,
but one other does stand out -
significantly. Over the same time
period mentioned above there
were in excess of 1,000 cited incidents
concerning documentation
including the following:
❍ Written procedures were nonexistent
❍
Written procedures were not
followed
❍ No written record of investigations
exists
❍ No cleaning and maintenance
records exist
❍ No periodic review of procedures
were conducted
❍ No written sanitation procedures
exist
❍ And other incidents related to
documentation
Documentation
One of the paramount issues related
to FDA-regulated products,
whether food or drug products, is
that of documentation and record
keeping related to manufacturing.
These industries are repeatedly
cited on this same issue. It includes
documentation required to cover
traceability of the product-contact
material used in constructing process
systems, and properly written
50 ChemiCal engineering www.Che.Com marCh 2014
ing or equipment will be in contact
with the product, it will require
traceability in the form of a heat
number that can be traced back to
the mill of origin. The heat number
is the tracking number found on the
Mill or Material Test Report (MTR).
If it is non-metallic, it will require
a Certificate of Compliance (C of
C) for batch traceability back to its
source of formulation.
This is all done with the intent
to hold originating and modifying
parties of a raw or finished product
accountable in case the product is
determined to be the source cause
for adulterating a food, drug, or cosmetic
product during production or
post-production handling.
The material used to build the
systems that manufacture food,
drugs and cosmetics have been carefully
selected and enhanced over
the years to prevent contamination
of a product through the inadvertent
introduction of undesirable
particulate matter into the product
stream. This can occur through the
leaching of non-metallic material or
the use of poorly passivated stainless
steel that could introduce iron
oxides into the product stream.
Procedures should be written and
followed, not only for the process itself,
but for clean-in-place (CIP) and
steam/sanitize-in-place (SIP) procedures
as well. All maintenance and
quality control procedures should
be written and followed, with signed
and dated log reports verifying the
frequency and intervals in which
these activities were performed.
Well written procedures, records,
and documentation are not
only proof to the FDA inspectors
that well-thought-out operational
programs were put in place, but it
shows due diligence on behalf of
the company, indicating that management
takes seriously the safe
and controlled manufacture of food,
drugs and cosmetics.
The ease of access to appropriate
documentation, its thoroughness, and
organization will pay dividends, not
Figure 2. Proper design specifications
will combine input from the three
sources shown here
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Chemical Engineering March 2014

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