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Cerilliant maintains a robust quality system founded on the principles of quality by design, risk management, and continuous improvement. We are accredited to ISO 17034, ISO/IEC 17025, and certified to ISO 9001.
Cerilliant has been collecting real time stability data on its products for years.
This data is collected as part of our normal release testing process whereby comparison
is generated to the prior lot to ensure lot to lot consistency and to a stability
lot to establish long term shelf life. As a part of our continuous improvement process
we implemented the concept of Retest Dates in 2006 on all products for which long
term shelf life data has not been collected. What this means is that we only put
Expiration Dates on products where we have collected sufficient real-time stability
data to allow us to assign a minimum 36 month expiry date. For all other products,
including most neat reference materials, we assign a Retest Date until we have collected
sufficient data to establish long term shelf life (36-60 months).
- Expiration Dates are assigned to established products and are determined through
real time stability studies. The Expiration Date defines the total shelf life of
the product. Cerilliant discontinues sales of these items 12 months prior to the
stated Expiration Date.
- Retest Dates are assigned to products for which long term shelf life has not been
fully established and to neat reference materials to ensure the continued collection
of data.
- Retest dates are assigned to new products and to products which are continuing on
stability testing.
- The retest date is assigned during product design, at the time of initial production,
or at a stability testing interval.
- As a general rule, all new products will be assigned a Retest Date until sufficient
data is gathered to establish a shelf life of 36 to 60 months (more for some neat
materials).
- Cerilliant warrants all products will meet the specifications outlined in the COA
through the Expiration Date or Retest Date (as applicable) providing products are
stored as stated on the COA or label. The warranty applies only to ampoules/vials
stored unopened.
This practice is consistent with the
regulatory guidance and ensures that Cerilliant products are thoroughly
and objectively evaluated for performance not just upon release but throughout the
shelf life of the product.
Retesting Process and Updated Certificates of Analysis (COA)
Cerilliant will test and recertify Retest dated products prior to the stated Retest
Date. New COAs will be posted upon completion of recertification. For Cerilliant
products, the Retest Date should be interpreted to be the end of the month stated
(May 2012 = May 31, 2012). Cerilliant warrants the product to meet the acceptance
criteria stated on the COA and suitable for quantitative applications (unless otherwise
stated on the COA) when used on or before the stated Retest Date. Qualitative use
of the product is not limited by the Retest Date.
- Solution standards are retested and recertified using a process that involves verification
of concentration and purity against the original acceptance criteria.
- Neat reference standards are retested and recertified by verifying purity and any
changes to the purity factor.
Upon successful re-certification a new retest date or expiration date is set for
the product. The Certificate of Analysis is then updated and made available on our
website. Customers who have signed up for electronic notifications will receive
an email notification any time a COA for a product they have purchased is revised
(see electronic notifications below).
Once sufficient shelf life data has been collected, the products in the stability/retesting
program are reclassified with the experimentally-determined Expiration Dates and
future lots will reflect an Expiration Date instead of a Retest Date.
In the event a product fails recertification and no longer meets the stated acceptance
criteria on the COA, a stability notification will be sent to all impacted customers.
Stability notifications are separate and apart from COA revisions.
Electronic Notifications
In the event a product fails recertification and no longer meets the stated acceptance
criteria on the COA, a stability notification will be sent to all impacted customers.
Stability notifications are separate and apart from COA revisions.
Email notifications of COA Revisions are made automatically anytime a Cerilliant
Certificate of Analysis has been revised. The email notification will contain a
link directly to the revised COA. Revisions may include update/extension of a Retest
Date or Expiration Date but may also include corrections of typographical errors
or a change to recommended long term storage conditions. Cerilliant COAs contain
a Revision History which should be consulted to determine the reason for the revision.
Notifications are made only to customers having purchased, within the prior 12 month
period, the item/lot that has been revised. Electronic notifications will only be
made to customers who have signed up for them. To receive these notifications please
contact Customer Service at custserv@cerilliant.com
and provide an email address that is specific for COA revision notifications.
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