Quality Risk Control On Clean Utilities Retrofit Engineering For Pharmaceuticals

Effects of medicine originate from successful controlling of its quality.As primary source of auxiliary material and washing agent and power,products of clean utilities system such as purified water and process compressed air have always been a focus of attention.Quality standard of purified water has several quantitative acceptance critetia in Chinese pharmacopoeia、European pharmacopoeia and USA pharmacopoeia;In the meantime,quality of process compressed air has clear regulation in national standard.It is critical source and basic fundamentals in production of each pharmaceuticals to ensure that clean utilities product qualified purified water and compressed air steadily and continuously.It is a necessary engineering procedure to introduce quality risk management concept to clean utilities retrofit engineering,and realization of risk assessment,furthermore to expand specific quality risk management on the assessment.As logical deduction process and quantitative risk assessment approach,failure mode and effect assessment has been widely applied in pharmaceutical industry.This thesis conduct system requirement from system function design,and draws system quality critical items,and then obtain relevant failure mode of corresponding quality critical items through brain storming method,and risk grading can be attained via expert review scoring.And use system validation and periodically maintain to verify and decrease quality risks to eventually product qualified purified water and process compressed air.