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CHF Buy. Life cycle Previously Withdrawn. Full report circulated: decision for new DIS ballot. Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks. Close of voting. Proof returned by secretariat. Added information on the most probable number MPN technique. New details on ways to improve limit of detection LOD. Removed some discussion of statistical methods for evaluating bioburden data where information was not typical or not required.
New table for the criteria for selection of a bioburden recovery efficiency approach. Explained the use of the correction factor CF. Provided more information on the application and performance of a bioburden method suitability test. New section for direct plate counts, estimated counts, and counts beyond the ideal range. New table clarifying where typical responsibilities reside for the manufacturer or the laboratory.
Increased focus on a risk-based approach. You may also like these posts:.
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