2008-03-10_GENERAL DOCUMENTS - M1977247

Home Browse Search

1 ACZ Laboratories, Inc. August 10, 2007 Quality Assurance Plan Version 12 SOPAD018.08.07.12 Page 31 of 96 8.4.2 Secondary Control Number (SCN) To ensure complete traceability, a unique SCN must be created when any intermediate or working standard is prepared from one or more stock solutions, stock chemicals, or intermediate solutions. A standardized format is used for creating the SCN: a two-letter code indicates the lab section and is followed by the prep date and then by a daily sequential number. For example, the SCN I1051128-2 denotes the second standard prepared on November 28, 2005 in the Inorganic Instrument lab. An acceptable alternative is to let LIMS assign a unique number when prompted. A SCN for any working standard subjected to a LIMS calculation must be created electronically in LIMS. The initial volume and concentration of each constituent and the final volume of the prepared solution are entered in the SCN Wizard program to calculate the final concentration(s) of each analyte using the formula CIV, = C2V2. The preparation date, expiration date, and preparer's initials are included as part of this electronic record. A hard copy of the SCN report may be affixed to the standard/reagent logbook, depending on individual department practice; however, it is not required. Prepared reagents do not require a SCN to be created electronically in LIMS; however, preparation ' must be recorded in the department's designated logbook. At a minimum, the logbook entry must clearly identify what reagent was prepared, its subcomponents, the preparer's initials, the preparation date, and the expiration date. This information is sufficient for color reagents, buffer solutions, ' instrument reagents, etc. because details of the preparation are stated in the test SOP. 8.5 Preparation and Expiration of Standards and Reagents ' 8.5.1 Preparation of Standards and Reagents Refer to individual test SOPS for detailed information regarding standard and reagent preparation. In general, either Class A pipettes or mechanical pipettes are used to measure and dispense aliquots of any solution used to prepare a standard or reagent. Accurate delivery of mechanical pipettes must first be verified as described in ACZ's SOP Control, Calibration, and Maintenance of Measuring and Test Equipment (SOPAD013). The term QS referenced in many test SOPS is the acronym for Quantity Sufficient and refers to the addition of appropriate diluent to the solution to achieve the final volume. All containers of prepared reagents and standards stored for more than one day must be properly labeled with the SCN (or other unique identifier), preparation date, and expiration date. Preparation of reagents and standards must be documented as described in 8.4.2. 8.5.2 Expiration of Purchased Standards and Chemicals (PCNs) In general, purchased liquid standards or reagents are assigned a default expiration date of one year ' from receipt. When provided, the manufacturer's expiration date will be assigned in lieu of the default expiration date. Solid materials are assigned a default expiration date of five (5) years from receipt. An expired stock material may continue to be used only if its reliability can be verified. For the purpose of ensuring transparency, the reason for extending the expiration date of a PCN must be documented as a QA/QC Issue Wizard assigned to QA/QC or the Document Control supervisor. Unusable materials must be replaced and the standard or reagent remade as soon as possible. Remove the container from the lab or the supply room and dispose of properly. Contact ACZ's CHO for assistance. 2773 Downhill Drive 970-879-6590 Steamboat Springs, CO 80487 www.acz.com