How To Handle Primary and Secondary Reference Standards in A Quality Control (QC) Laboratory?
In this article, we’ll learn about multiple requirements/guidelines prescribed by sections 11.17, 11.18, and 11.19 of ICH Q7 to handle primary and secondary reference standards
Learn how to handle other standards including laboratory reagents and standard solutions
Requirements
to handle primary reference standards
Section 11.17 of ICHQ7 prescribes primary reference standards that should be
obtained as appropriate for the manufacture of APIs. The source of each primary
standard must be recorded. Records of each primary reference standards storage
and usage should be maintained by the supplier’s recommendations. It is
necessary to have primary standards in the QC laboratory for testing and
release of materials during manufacturing. The source of such standards has to
be documented fully.
The sources generally are from USP or EP. They supply
the primary standards as current reference standards (CRS). These primary
standards are identified with a specific lot number. For this purpose, you have
to visit the respective official website and download the COA. Document this
information along with the certificate of analysis. The primary standard gets
replaced with fresh slots. There should be a detailed procedure in your sop on handling
primary standards. The procedure should describe how frequently the respective
website is checked to find out if there is a change in the lot number.
It is necessary to replace the old standard with
a new one whenever a new lot is available. Read the usage instructions
carefully before using the primary standards. Appropriate storage conditions
have to be followed as recommended by the supplier. Some standards may have to
be stored at 2 to 8 degrees Celsius or 25 degrees Celsius or in different
temperature conditions. Certain standards are hygroscopic and need to be
protected from accidental ingress of traces of water unless such standards are
stored well protected in a desiccator with active desiccant they can lose their
potency. So, it is very important to adhere to the storage conditions as
recommended.
Primary reference standards from an officially acknowledged source are normally used without testing if stored under conditions consistent with the supplier’s recommendations. The official standards are already qualified at the source hence it is not required to test once again. They are well elucidated for chemical structure impurities and purity established fully at the source. However, those sources may not provide us with such data for our records. It will be archived at the source site also the standards will not give complete analytical data on the standard. It gives only information on potency or levels of impurities etc. It's also important that they are stored as recommended to avoid any deterioration.
Section 11.18 prescribes when a primary reference standard is not
available from a recognized resource, then an in-house standard should be developed.
Appropriate testing should be performed to establish the identity and purity of
the primary reference standard. Furthermore, appropriate documentation of this
testing should be maintained. This section is important when there is no
primary standard available from any of the official sites it is necessary to
have an in-house primary standard prepared.
Let us understand what is a primary standard it
is a fully characterized and qualified substance the characterization of a
chemical compound is established for its chemical structure. How the functional
groups are arranged is molecular weight information on elements like carbon,
nitrogen, hydrogen, etc. With this step, the identity of the compound is
established.
What is the qualification? The qualification of
a compound is established for its purity levels of impurities all these testing
details to establish the identity and purity of the compound have to be
documented completely.
Requirements
to handle secondary reference standards
Section 11.19 prescribes secondary standards should be appropriately
prepared identified tested approved and stored. The suitability must be
determined for every batch of secondary standards before use by comparing it
with the primary standard. Furthermore, every batch of secondary reference standards
must be re-qualified by a written protocol periodically.
A secondary reference standard is an alternative
standard to a primary standard there should be a detailed procedure for
preparation of the secondary standard, if necessary, the available material may
be reprocessed to make it qualify as a standard. The secondary standard
prepared should be evaluated against the primary standard this secondary
standard may be used for routine analysis.
The secondary standard has to be re-qualified using the CRS with a frequency that may be once a year. The detailed protocol should be made with the identification of the source material any reprocessing for purifying to meet the standard quality etc. How to be part of the protocol.
Being a certified supplier of analytical reference standards, we have a wide range
of primary and secondary reference standards for both API and impurity. This
exclusive variety of reference material can be used in several industries
including pharmaceutical, beverage, dairy, pulp & paper, wine, and many
more. If you are looking for analytical reference standards, contact us to share
your requirements for authentic and custom solutions.
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