Last week I attended a meeting with FDA staff from the
Denver District Office. The meeting was
an annual update from FDA addressed to the members of the Rocky Mountain
Regulatory Affairs Society. Since most
of the members work with medical devices, the speakers from FDA focused on that
industry sector and in particular talked about Purchasing Control Regulations
since failure to comply with them results in a large number of failed
inspections, warning letters and product recalls each year. The term “Purchasing
Controls” is only used in the regulations for medical devices but the language
of these regulations are informative for dietary supplement, food and cosmetic
companies as well.
The regulations covering good manufacturing practices (GMPs)
for dietary supplements commonly use the phrase, “ensure that the [product,
components, labels and packaging] are consistent with your purchase order”. The GMP regulations for foods and the GMP
guidance for cosmetics both refer to specifications for ingredients. Since it is impossible to consistently make
quality products unless you have ingredients of consistent quality, it is
imperative that your purchasing department have detailed information about the
requirements for each ingredient or component used in your product. In other words, purchasing needs detailed
ingredient/component specifications.
Let’s take a brief look at the medical device purchasing control
regulations to learn more:
21 CFR 820.50(b) states, “Each manufacturer shall establish and maintain data that clearly
describe or reference the specified requirements, including quality
requirements, for purchased or otherwise received product and services…”
This could mean that the herbs you purchase must be
accompanied by chromatograms that document the amounts of key phytochemical
components. It may mean that you must
list a range for the required viscosity of certain oils to ensure that your
cosmetic will have the right thickness.
In the case of a food ingredient such as cayenne pepper, it may be important
to define the acceptable Scoville Heat Units so that the final product will
live up to your label claims of mild, medium and hellfire.
21 CFR 820.50(b) continues, “Purchasing documents shall include, where possible, an agreement that
the suppliers, contractors, and consultants agree to notify the manufacturer of
changes in the product or service so that manufacturers may determine whether
the changes may affect the quality of a finished device.
This is a very important consideration for companies that
are using contract manufacturers. Your
contract with your manufacturer should explicitly define not only which
ingredients may be substituted but what substitutions are acceptable and that
you are to be notified when the manufacturer finds it necessary to make any
change to your product.
As specified in the device regulation, the best way to
ensure that you always get quality ingredients and services is to first set
requirements/specifications for your ingredients, components and service providers
and then evaluate their ability to meet your requirements before you contract
with them. If your company has purchasing controls that are followed and
followed up on by the quality and manufacturing departments it is far more
likely that the products, components, labels, etc. will be consistent with your
purchase order and meet your specifications.
That in turn will please your customers!
I started my consulting business in 2001 after 15 years
working in FDA-regulated industry. Since
that time my colleagues and I have served hundreds of dietary supplement, food,
cosmetic and device companies from around the globe. My colleagues and I are ready to help you
determine which FDA regulations apply to your product and what you need to do
to comply with them. Contact us today by replying to this message.
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