36 ISE Magazine | www.iise.org/ISEmagazine
Getting
to
good
important to educate employees about
how to think critically and how to make
time-sensitive decisions such as when to
notify a supervisor of a problem, when
to halt production, when to consult out-
side expertise and, if necessary, when to
recall a product. SOPs can be an effec-
tive tool that helps companies find an
appropriate balance between encour-
aging employees to respond decisively
to GMP-related adverse events while
preventing individual operators from
making more generalized changes to a
process without supervisory approval
and revised documentation.
Although the FDA has not defined
specific criteria for achieving a state
of "good manufacturing practice" for
food packaging beyond the general
safety requirement, one can infer that
standard industry practice is sufficient
when standard industry practice protects
the health and safety of the consumer.
Heroic measures are not required, but
corporate culture and consumer expec-
tations can effectively influence com-
panies to exceed minimum standards.
Technical limitations may serve as a
justifiable limit on the scope of GMP;
economic considerations, however, are
certainly less defensible.
When evaluating good manufactur-
ing practice in a facility, manufacturers
of food-contact materials should con-
sider: (1) the present state of the industry
at large; (2) the availability of current
and emerging technologies; and (3) the
degree of risk inherent to the consumer's
intended or reasonably foreseeable use of
the product. It follows that meeting the
minimum requirements for GMP in
2018 may not be sufficient for achieving
that same goal 10 to 20 years from now.
Therefore, companies should continu-
ally strive to offer maximum value and
quality, while simultaneously endeavor-
ing toward continuous improvement.
Da iel C. Rube stei s a ssociate at
Keller a d Heckma LP based i ash-
i gto , D.C., a d is a member of the firm's
food a d drug practice group. Rube stei
assists compa ies, orga izatio s a d trade
associatio s i stablishi g complia ce with
regulatory requireme ts for food packagi g
materials a d food i gredie ts throughout
the U ited States, Europea io , Asia
a d South America. Leveragi g his tech ical
backgrou d a d expertise as a dustrial e -
gi eer, Rube stei as experie ce i rocess
optimizatio , i ve tory co trol, facility layout
a d good ma ufacturi g practice i DA-reg-
ulated facilities. Rube stei ses this experi-
e ce to help clie ts develop quality co trol a d
i ter al auditi g strategies, sta dard operati g
procedures a d rapid-respo se pla s.
Other resources
The Food and Drug Administration has a number of publicly available resources for help with food safety, recalls and manufacturing
practices. In addition to the websites below, Keller and Heckman LLP provide a comprehensive online resource at www.packaginglaw.com:
• FDA's webpage for identifying and monitoring recalls: www.fda.gov/safety/recalls/
• Common foodborne illnesses and contaminants: www.fda.gov/Food/FoodborneIllnessContaminants/default.htm
• General information on food packaging: www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm
• The food-contact notification (FCN) program has a publicly available, searchable inventory: www.accessdata.fda.gov/scripts/
fdcc/?set=fcn
• FDA's Office of Food Additive Safety also posts helpful information that assists companies in evaluating the safety of food-contact
substances, including in the context of FCN submissions:
– Chemistry guidance: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
IngredientsAdditivesGRASPackaging/ucm081818.htm
– Toxicology guidance: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081825.htm