GOOD MANUFACTURING PRACTICES

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Five Things You Need to Know about the GMPs

By Michael Tousey and Carol Brennon

1. If it isn’t written down, it didn’t happen.
There’s an old saying in many regulatory and quality
departments: “If it isn’t written down, it didn’t happen.”
That is because during an FDA inspection, companies
must be able to demonstrate GMP compliance. One of the
most critical ways this is accomplished is by providing
written proof that your company actually does what the
regulations and your procedures say. Make sure all
cleaning, training, and procedural activities are docu-
mented properly.
2. Many pest-control programs are inadequate.
4. Written procedures should match what your employees
and processes do.
For many companies, it would be easy to make the state-
ment that if they only did what was written in the standard
operating procedures (SOPs), the process would not be
successful. How many times do your operators say their
SOPs don’t work? Once is too many! Procedures must
match what is being done or there is a problem, not just
from the FDA investigator’s perspective, but because your
company is not functioning optimally. Your procedures
and processes must accurately reflect actual practices,
while adhering to regulatory requirements.

Your company has a pest-control program—but will 5. Audits are not just for accountants and the IRS.
it stand up to scrutiny? This is one of the areas many
companies receive an If there is one message
inspection observation to deliver, it is that we
for, and the reason is are all part of the quality
that their programs team, all of the time. Did
are inadequate. A com- you know that FDA re-
prehensive pest-con- quires companies to con-
trol program carried duct self audits? It is
out by a qualified pest- important that your com-
control company, pany has an internal
documented complete- audit program to deter-
ly and accurately, is the mine your compliance to
way to go. This is not regulatory requirements,
an area to try to save as well as adherence to
money by delegating it your own company spe-
to the company janitor cifications and proce-
or hiring a nonprofes- dures. This does not mean
sional company. Get you must create a new
your pest control pro- department in your com-
gram in good order. pany, though. You may
All cleaning, training, and procedural activities should be documented as a means of
demonstrating compliance with the GMPs. Photo courtesy of Bergstrom Nutrition. use the service of an au-
3. Your employees diting company—just
must be trained and qualified. make sure that you have carefully created your audit pol-
icies that state the expectations of your audit program.
GMPs require that all employees be trained and qual- With the requirements of the new dietary supplement
ified to perform their duties. So, how will your employ- GMP ruling, companies are being motivated to take
ees stack up when their training records are examined action now. The first step is to complete a GAP assessment
during an FDA inspection? Your employees must be audit. A GAP assessment determines where your compa-
trained for each task they perform. Who trains them? ny is now and where it needs to be. Step two is to create
Who qualifies that the training was effective and the and execute a plan for compliance. The final step is being
employees are now trained and ready to perform their active and prepared for an FDA inspection. You do not
duties? How is the trainer qualified? Yes, these are all have to do this by yourself with your own staff; you can
questions you may be asked during an inspection. Be hire outside help.
ready to answer them and provide procedures for how
these activities are performed and documented. Don’t Michael Tousey is technical services director and owner of
stop there! Focus on the quality of your employees, too. Techceuticals (Bluffton, SC). Carol Brennon is a quality audi-
Build pride into your process and allow the operators to tor and GMP consultant. For more information, visit
grow along with quality and productivity. www.techceuticals.com or call 800/272-8191.

Reprinted from Nutritional Outlook, January/February 2008 • Copyright © 2008 Canon Communications LLC