suppliers should be contractually obligated to notify their customers of any
significant changes. The impact of any
changes in raw materials or processes
should be evaluated before they are
implemented. Finally, food contact and
nonfood contact materials should be
Manufacturing procedures should
be written out and available at work-stations. The written procedures
should include specific raw materials and
amounts, identification of critical points
in production that
need monitoring, and
required testing. Procedures that should
be taken to correct
any deviations should
also be specified. All
employees should be
trained in GMPs, and
details of the training
should be specified.
The process for
the management of
changes—such as the source of raw materials, a product formula, or the production process—should be written out. It
is important to clearly document the
management hierarchy so it is clear who
may approve specific types of changes.
Documentation and record keeping are critical to demonstrating that
a manufacturer is conforming to its
Standard Operating Procedures. Including all the factors mentioned above in a
GMP manual will minimize the chance
As discussed above, GMPs should
ensure that FCSs meet legal prerequisites for safety and quality, and while
this article focuses on U.S. legal requirements in our global economy, GMP requirements of other countries may need
to be considered as well. In the European Union, for example, food contact
materials are subject to the Framework
Regulation (EC) No. 1935/2004 and the
GMP Regulation (EC) No. 2023/2006.
The Framework Regulation specifies
that food contact materials and articles
must be manufactured in accordance
with GMPs, so that they do not transfer
their constituents to foodstuffs in quantities that could endanger human health
or bring about an unacceptable change
in the composition of the food or its
Once legal safety requirements are
met, customers may require further as-
surance that FCSs and
products are safe and
of a certain quality.
For instance, many
especially large international ones, are
mandating that their
packaging suppliers be
Global Food Safety
Initiative (GFSI) certified.
GFSI was founded in
2000 due to concerns
audit systems and in-
them. GFSI establishes requirements
for food safety management schemes
and provides a framework against which
these schemes can be benchmarked. The
organization does not undertake any
accreditation or certification activities.
Several certification programs for
manufacturers and converters of packaging and packaging materials are currently recognized by GFSI, namely, the
British Retail Consortium, FSSC22000,
IFS PACsecure, and the Safe Quality
Food program. 4 The GFSI-benchmarked
food packaging standards establish a
minimum set of requirements. One of
these requirements is to have a Hazard
Analysis and Critical Control Points
(HACCP) program in place. Unlike
GMP inspections that can be flexible,
GFSI-benchmarked audits are defined
by the owners of the standard.
A HACCP plan can be included
in a company’s GMPs. Its basis is to
identify, evaluate, and control hazards.
For packaging, these can include foreign
objects or chemical contamination.
The seven principles of an HACCP
• Conduct a Hazard Analysis;
• Identify the Critical Control Points
(CCPs) where control can be applied
to prevent, eliminate, or reduce a
• Determine limits for each CCP;
• Establish monitoring to ensure that
limits are being met at each Control
• Establish corrective actions when
limits are not met;
• Establish record-keeping procedures;
• Verify that the program is working.
In summary, FDA’s GMP regulation
for indirect additives is fairly general
and includes the following requirements
for food contact materials and their
components: They should be suitably
pure and comply with other provisions
of the FD&C Act; they must not render
food unfit for consumption; and they
should not be used at a level greater
than necessary to achieve the intended
This being said, as greater attention
is focused on the role of packaging in
food safety, whether justified or not,
food manufacturers may require their
packaging supplier to establish compliance with food safety certification programs that go beyond current requirements. But that is a subject for another
George G. Misko, Esq., is a partner in the Washington, DC, office of Keller and Heckman LLP. He can be
reached at firstname.lastname@example.org.
1. See Food Additives: Hearings on Bills to
Amend the Federal Food, Drug, and Cosmetic
Act with Respect to Chemical Additives in Food
Before a Subcommittee Of the House Committee On Interstate & Foreign Commerce, 85th
Cong. 44 (1958); at 447 (testimony of Jerome H.
Heckman, Society of the Plastics Industry).
2. 21 C.F.R. Section 174.5.
3. 21 C.F.R. Part 117.
4. See www.mygfsi.com/certification/
Keller and Heckman does not endorse any specific certification or audit program.
“The most critical
GMP requirement for
packaging materials is
that they be suitably
pure for their