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Tips on Testing
Ingredient testing is a responsibility
for both raw ingredient suppliers and finished product manufacturers
in many ways. From start to finish, this portion outlined
in the cGMP is defined by such factors as purity, strength,
metal levels, and any other components that may directly affect
the quality of the ingredients. If not done properly, it can
cost a company time, money and/or worse – a severe disciplinary
action from the FDA.
Final Rule § 111.320 (a) and (b) requires that all manufacturers
verify that laboratory examination and testing methodologies
are appropriate for their intended use; and that they be indentified
and used appropriately according to valid scientific methods
for each established specification. Understanding the types
of testing available and applicable to your ingredients is
crucial in creating a smooth process from purchasing and R
& D to the finished products for distribution.
| Term |
Definition |
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| Identity |
The dietary supplement’s
consistency with the master manufacturing record and/or
that it is described in the master manufacturing record.
The substance or product represented on the label. |
|
| Purity |
The portion or percentage
of dietary supplement that represents the intended product.
|
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| Strength |
The concentration level
of a dietary supplement. The quantitative amount per serving,
such as weight or volume. |
|
| Composition |
The specified mix of
product or product-related substances in a dietary supplement.
|
|
| Methodology |
A method or procedure
used for a specific type of test result. |
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Here are some common tips to consider
when testing your dietary supplements.
1. Make sure you understand the types of test results you
are requesting from your ingredient distributor. For example,
manufacturers may not use the same types of testing. The HPLC
test result cannot be compared to the Titration or UV test
method. A product’s purity may be 1%, but the ingredient
may be sourced from different manufacturers that use different
fillers.
2. What are some common tests methods used for dietary supplements?
Assay, identification, heavy metal and microbial.
3. If you decide to use a 3rd-party lab testing facility,
make sure they use authentic references, calibrate the instruments
on a routine basis and maintain skilled lab personnel. Testing
can be a costly but necessary procedure for some manufacturers,
so it is important to do your homework when it comes to choosing
a 3rd-party lab. Make sure the lab uses an authentic reference
sample instead of comparing it against a previous lot number.
4. What documents should be reviewed for testing information?
Review the COA for the type of test methods prior to testing
the product.
5. What are some things that may affect the test results
of a product? If the product is not pure or if it contains
a filler, the manufacturer will need to use a different form
of identification (or labeling). It is important to understand
that different fillers will affect the profile of the sample
and the testing.
Source:
CGMP Definitions Applied to Final §111.3 (page 199)
What Requirements Apply to Laboratory Methods for Testing
and Examination? (page 565)
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