2008-03-10_GENERAL DOCUMENTS - M1977247

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ACZ Laboratories, Inc. August 10, 2007 , Quality Assurance Plan Version 12 SOPAD018.08.07.12 Page 32 of 96 8.5.3 Expiration of Prepared Standards , Storage conditions and shelf life for prepared standards are provided in the individual test SOPS. The following guidelines may be used to determine the shelf life for a prepared standard: ' 1) A standard that has been prepared in-house may continue to be used after its assigned expiration date for as long as its reliability can been verified. For applicable procedures, instrument response should be considered when determining whether or not a solution is still reliable. • In cases where reliability has been verified, the expiration date of the SCN must be updated in LIMS or the standard/reagent logbook. • In the event the solution was used prior to updating the SCN then documentation must be provided as part of the workgroup to indicate the solution was used past the shelf life stated in the SOP (a minor corrective action may be used if more than one workgroup is , affected). The expired standard must be remade as soon as its reliability becomes questionable - it is the responsibility of the analyst to use their best judgment. 2) The shelf life of any prepared standard with any analyte concentration < 10 mg/L is 90 days from the preparation date. This is a general guideline - if any constituent does not remain in solution for 90 days, then the standard must be prepared more often. If the manufacturer's expiration date for any stock standard is sooner, then the expiration date of the SCN is the ' manufacturer's expiration date for a single analyte solution or the earliest manufacturer's expiration date for a multiple analyte solution. 3) The shelf life of any prepared standard with analyte concentration > 10 mg/L is one year from t the preparation date. This is a general guideline - if any constituent does not remain in solution for one year, then the standard must be prepared more often. If the manufacturer's expiration date for any stock standard is sooner, then the expiration date of the SCN is the , manufacturer's expiration date for a single analyte solution or the earliest manufacturer's expiration date for a multiple analyte solution. 4) In general there are no manufacturer expiration dates for Radiological isotopes. If provided, ' these will be used; otherwise, the default expiration date of one year from receipt will be assigned when the material is received and can be subsequently updated at yearly intervals as needed for as long as the material remains useable. Because the shelf life of a radiological ' isotope is dependent on the half-life, the isotope will be deemed expired when it falls within 3 times the detection limit of the method. 5) In general, prepared Radiochemistry standards expire one year from the preparation date. The solution may be re-evaluated using control charts or other criteria and the expiration date extended by year intervals if the solution is still deemed usable. Refer to the specific test SOP for details. 8.5.4 Expiration of Reagents , In general, a reagent is a solution, other than a surrogate or internal standard, which is used for any step of sample preparation or analysis but does not contain the target analyte(s). Storage conditions and shelf life are stated in the individual test SOPS. The expiration date can be extended for a prepared reagent provided the criteria stated in 8.5.3.1) are met. ' 2773 Downhill Drive Steamboat Springs, CO 80487 970-879-6590 , www.acz.com