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OMB MEETING MATERIALS

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iii. Target measurement uncertainty for the pharmaceutical industry is discussed in “ Fitness for Use: Decision Rules and Target Measurement Uncertainty ”; USP Pharmacopeia Forum 42(2), Stimuli Article, usp.org f. Metrological traceability i. Metrological traceability is not directly required by cGMP; however, traceability to standards such as USP reference materials is often required. g. Out of Specification results (OOS) i. OOS would be dealt with under Nonconforming work in ISO/IEC 17025. The cause analysis and risk assessment for OOS results is rigorous and defined in detail in the cGMP. i. ISO/IEC 17025 emphasizes the risk analysis approach to processes and procedures. It does not prescribe procedures and emphasizes outcomes. The use of risk analysis to control outcomes is in line with the ICH Q9 Quality Risk Managemen t guide. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html h. Risk analysis and ICH Q10, 11, 12

08/09/2018