|
 |
 |  |
Cerilliant maintains a robust quality system founded on the principles of quality
by design, risk management, and continuous improvement. We are accredited to ISO
Guide 34, ISO/IEC 17025, and certified to ISO 9001:2008. Our quality system incorporates
GMP and GLP requirements.
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.
Regulatory Guidance
The practice of assigning retest dates is the recommended procedure in the US Food
and Drug Administration’s Guidance for Industry document to the pharmaceutical industry:
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (API’s)
and is standard pharmaceutical industry practice for reference standards. Per the
Q7A:
“An API expiry or retest date should be based on an evaluation of data derived from
stability studies. Common practice is to use a retest date, not an expiration date.”
“Retest Date: The date when a material should be re-examined to ensure that it is
still suitable for use.”
“Expiry Date (or Expiration Date): The date placed on the container/labels of an
API designating the time during which the product is expected to remain within established
shelf life specifications if stored under defined conditions and after which it
should not be used.”
Consistent with our accreditation to ISO Guide 34, expiration dates are assigned
to Cerilliant products based on stability studies:
ISO Guide 34, Section 5.9.4, defines Expiration Dates as “An assessment of the stability
of the assigned property values of the reference material performed at periodic
intervals after characterization to confirm that all values are maintained from
production until its expiry date. Wherever appropriate, the reference material producer
shall provide an expiry date for the useable life to the reference materials produced,
based on initial and on-going stability studies in compliance with ISO Guide 35.”
ISO 17025 does not specifically speak to the assignment of expiration dates or retest
dates. It does speak to the calibration of equipment and the use of certified reference
standards as follows:
Section 5.58 – “Whenever practicable, all equipment under the control of the laboratory
and requiring Calibration shall be labeled, coded, or otherwise identified to indicate
the status of calibration, including the date when last calibrated and the date
or expiration criteria when recalibration is due.”
Section 5.6.2.1.2 – “There are certain calibrations that currently cannot be strictly
made in SI units. In these cases calibration shall provide confidence in measurements
by establishing traceability to appropriate measurement standards such as: - the
use of certified reference materials provided by a competent supplier to give a
reliable physical or chemical characterization of a material…”
Section 5.10.4.3 - “A calibration certificate (or calibration label) shall not contain
any recommendation on the calibration interval except where this has been agreed
with the customer. This requirement may be superseded by legal requirements.”
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). As long as testing is performed on or before the stated
Retest Date (either the original Retest Date or an extended Retest Date) under a
valid Cerilliant COA, then Cerilliant warrants the product to meet the acceptance
criteria stated on the COA and suitable for quantitative applications (unless otherwise
stated on the COA). 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 (www.cerilliant.com). 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).
For products labeled with a Retest Date, Cerilliant will also provide updated product
labels upon request to any customer having purchased the product/lot. Please contact
Cerilliant Customer Service (custserv@cerilliant.com)
to request new labels and provide product number and lot number. For all products
labeled after April 17, 2009, products with a Retest Date will show “Expiration:
See COA” on the product label eliminating the need to re-label upon extension of
a Retest Date.
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
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 14 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.
The current Cerilliant COA is always available via our web site multiple ways:
- Products > Search COA/MSDS - Supply the Item# and Lot# and click Search. The corresponding COA will be displayed.
- Search Catalog – Enter the Item # into the search box. Click through to the item detail page, click on COA to view COA of the Current Lot.
- Products > Catalog - Use the categories to find your item. When you find your item, Click through to the item detail page, click on COA to view COA of the Current Lot.
- My Account > Order History (requires login) - Select the desired Invoice. On the corresponding Invoice Detail page, mark the checkboxes for the lines that COAs are needed. Choose the Print or Save option.
|
|
|
|