EFfCI GMP Position Paper Certificates of Analysis
EFfCI GMP Position Paper Certificates of Analysis
EFfCI GMP Position Paper Certificates of Analysis
Position Paper
Definition
The Certificate of Analysis is primarily a means of communicating the analytical results
on the batch or lot. Other statements may be included where relevant to ensuring the
quality of the material.
1. The name and address of the company responsible for issuing the CofA,
2. A unique identifier for the product, for example the item number or product code
of the ingredient,
3. The batch or lot number,
4 The date of the release of the batch, or date when the batch has been retested,
5 The Expiry or Retest Date, or, the period of time until the Expiry or next retest
date is reached,
6 The specified parameters and the analytical results,
7. A reference to the test procedure used, including the acceptance criteria (limits
and units of measure),
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8 An indication if an analytical result was obtained from a statistically based
testing program,
9 The quality unit role who approved the CofA.
Where the certificate of analysis comprises more than one page, each page of the
CofA should clearly be referenced to the batch in question.
Batch traceability
Equally the results have to be assigned to a specific batch or lot of material. The
Certificate should indicate the batch or lot number uniquely.
Dates
Many dates may be indicated on the Certificate, but in each case, it should be clear
what the date refers to, for example:
Retest date:
The definition in the EFfCI GMP for Cosmetic Ingredients is:
The date beyond which the cosmetic ingredient should not be used without
further appropriate re-examination.
This repeated batch release analysis should demonstrate that the product still
conforms to the specification.
Expiry date:
The definition in the EFfCI GMP for Cosmetic Ingredients is:
The date beyond which, a product may no longer conform to relevant
specifications.
Expiry date or expiration date is the date a product is expected to be no longer
usable for the named purpose and may only be suitable for disposal. It is
uncommon for cosmetic ingredients to be assigned an expiry interval but may be
assigned for ingredients which have a short stability interval e.g. ingredients
originally intended as food ingredients.
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Normally the organisation holding a batch which has expired can test it to check
if it still meets specification, and if so, they may be able to immediately use the
batch.
Shelf life:
Use of this term should avoided as it may refer to retest interval or expiry interval,
or indeed some other interval.
Many dates can be included on the CofA. It should be clear what these dates refer to.
Each date should be stated using an unambiguous date format so that readers do not
confuse the months and days for example in US and EU date formats (e.g.: month
reported as shortened name).
If the results are determined by statistical methods, then this should be made clear on
the Certificate. Statistical methods include checking the parameter periodically, for
example once a year rather than on every batch or testing some fraction of the number
of batches produced. In these cases, the result should not be numeric but a statement
of conformance to the limits. The use of a statistical method may be indicated in a
footnote on the CofA.
Any units of measurement should be quoted where the method has a quantitative
result.
Specifications and certificates of analysis should have the same parameters and limits.
Results should be reported along with the specification requirements for that test.
The same decimal digits for result and acceptance limit should be used.
Recertification
This is a process which extends the retest period. As batches come close to the first
retest date, they can be examined again using a combination of internal data and
product knowledge, and repeat analysis to recertify the batch. Normally when a retest
date is assigned, every batch will be recertified at least once. The assignment of the
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next retest interval will depend on the latest test results in relation to specification limits
and on experience with the product. A new CofA with updated results may be issued.
When a batch is recertified a new retest date or retest period should be displayed on
the certificate of analysis.
Signatures
A signature (physical or electronic) is not essential. An electronic one giving equivalent
assurance to a physical one may be included as part of the Certificate. Measures to
ensure electronic signatures are secure and attributable to the named individual
include having unique and personal logins and passwords to the applications
producing certificates of analysis.
Other Information
It is preferable to keep the contents of the certificate of analysis to the results of
analytical testing and the necessary information to allow traceability (origin, results and
records etc.).
Other information may be required by customers, but these are better managed in
separate documents as they can otherwise increase the size of the document and act
to slow down the customer goods receipt processes.