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Analysis of the
Certificate of Analysis (COA)
Having all the right documentation covers several areas when
it comes to manufacturing and distributing raw ingredients
and products to the consumer. Each Certificate of Analysis
(COA) contains information so important to the handling party
that if not reviewed correctly, could cost those companies
heavy fines or worse – the demise of their business.
Things like lead levels, physical appearance descriptions,
salmonella test and pH values are included in the COA, and
are important to several processes listed in the cGMP.
The following is a list of information that should be included
in each COA:
The name and address of the laboratory performing the tests.
The registration number of the certificate of analysis.
The name, description (i.e. grade, quantity received, type
of container) and number (used by the original manufacturer
and re-packer/trader) of the batch for which the certificate
is issued, the date of manufacture, and the expiry date (or
retest date).
The date on which the batch for which the certificate is issued
was received.
A reference to the test procedure used, including the acceptance
criteria.
The results of all tests performed on the batch for which
the certificate is issued and a comparison with the established
acceptance criteria (limits).
Any additional test results obtained on samples from the batch
as part of a periodic statistically based testing program.
A statement indicating whether the results were found to comply
with the requirements.
The date(s) on which the test(s) was (were) performed.
The signature of the head of the laboratory or an authorized
person.
The name, address, telephone and fax numbers of the original
manufacturer. If supplied by re-packers or traders, the certificate
should show the name, address, telephone and fax numbers of
the re-packer/trader and a reference to the original manufacturer.
A statement of the expected conditions of shipping, packaging,
storage and distribution, deviation from which would invalidate
the certificate.
A copy of the certificate generated by the original manufacturer,
if the sample is supplied by a re-packer or trader.
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