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Everything posted by JHH1999
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FDA variance for monthly standardization of digital therm.
JHH1999 replied to tgriffin's topic in Accrediting Agencies
If referring to 21 CFR 606.60( a variance request is no longer needed when following manufacturer's instructions for a digital thermometer. See the link below: http://www.fda.gov/cber/blood/exceptions.htm Hope this helps. -
5.1.4.2 makes patient and donor antibody samples useless for typing since most will not meet FDA requirements. Good luck finding some of the rares that react at least 2+ undiluted (i.e. Lutherans, Jsa) and finding cells to rule out all contaminating antibodies. 5.1.4.2 Reagents prepared by the laboratory and used in lieu of commercial reagents shall meet or exceed applicable FDA criteria.††FDA memorandum dated March 1992 “Recommended Methods for Blood Grouping Reagents Evaluation†(draft) [Docket No. 84S-0181]. 21 CFR 660.25 and 660.33.
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Most blood bank reagents are extremely stable. The manufacturers must have stability data to support the performance of the reagents over the expiration dating period. The definition of a lot is that the material was once a single large batch. The large batch is filled into multiple single units. Based on this type of manufacturing what is in vial number 1 is the same material that is in vial number 2000 and so on. As long as individual vials are stored in the same manner they will all perform the same. Therefore performing reagent QC on each newly open vial would be a waste of time and costly reagent. Performing QC once a day on a lot should be sufficient.