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usp data integrity quality control rca root cause analysis analytical development regulatory aqbd analytical quality by design cause and effect diagram fishbone analytical control strategy ep doe ishikawa risk assessment analytical target profile method development european pharmacopoeia design of experiment recovery negative control tymc tamc suitability protocol method suitability microbial limit test product control united states pharmaceopoeia sop cfu qc total aerobic microbial count total yeast and mould count ep chapter 2.6.12 ep chapter 2.6.13 risk management particle size distribution laser diffraction wet and dry analysis design of experiment (doe) risk prioritization number (rpn) failure mode and effects analysis (fmea) method operable design region (modr) method validation. oos oos process oos investigations deviation investigation 5 why's approach problem solving tools problem solving process process risk management target measurement uncertainty global regulatory update regulatory update ich united sstates pharmacopoeia international conference on harmonization modr control strategy method validation method qualification analytical method validation analytical method development r&d research and development eurachem iso/iec98 analytical method measurement measurement uncertainty data quality continuous improvement quality assurance performance parameters validation stability stress testing pharmaceuticals degradation acid stress base stress oxidative stress uv stress heat stress humidity stress risk management for analytical methods ich method design space fmea heat maps design of experiments quality by design anova qbd analytical quality bydesign factorial design raw data meta data recording data data lifecycle staticelectronic record dynamic electronic record root causes of data integrity violations electronic records violations data review data approval human error total quality management tqm lean six sigma atp design space method operable design region