Cerilliant maintains a robust quality system that incorporates continuous improvement as a basic philosophy. Cerilliant implemented the assignment of retest dates (as opposed to expiration dates) on certain products in 2006 as part of our continuous improvement process. Retest dates are differentiated from expiration dates as follows:

• Expiration dates are assigned to established products and are determined through real time stability studies. Cerilliant warrants these products through the expiration date (when products are stored as stated on the COA (Certificate of Analysis)/label). The Expiration Date defines the total shelf life of the product.
• Retest dates are assigned to products for which stability has not been fully established. 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 stability data is gathered.

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 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 COA

A retest date is a date before which the product will be tested and recertified. Cerilliant generally initiates retesting two months prior to the retest date. Products are certified to meet their labeled values up until the retest date. Continued use of the product as a quantitative reference material beyond the retest date is contingent upon successful recertification.

• Solution standards are retested and recertified using a process that involves verification of concentration and purity.
• Neat material 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).

Upon completion of recertification, new labels (reflecting an updated retest or expiration date) will be provided, upon request, to any customer having purchased the product being recertified. Please contact Cerilliant Customer Service (custserv@cerilliant.com) to request new labels. Please provide product number and lot number.

Once sufficient stability 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, a stability notification will be sent to all impacted customers.

Notifications of COA Revisions will be made available to all Customers that have purchased a standard within 14 months of any COA Revision. To receive these notifications please contact Customer Service at custserv@cerilliant.com and provide an email address that is specific for COA revision notifications.