GMPWaterSystem(cGMP培训系列1)-课件.pptxVIP

GMP Water System GMP水系统;Disclaimer; Part I Water Pre-treatment ;Water Introduction and treatment 水的引入和处理 ;Objectives目标 Introduction to Water for Pharmaceutical Use Review WHO GMP guidance Sources and types of water for pharmaceutical use Storage of bulk, untreated raw water Pre-treatment of water;Principles (1) Like any starting material, water must conform to Good Manufacturing Practice norms It must be “potable” and comply with WHO Guidelines for drinking-water quality 原则 1 ? 必须符合GMP对原料的基本要求 必须至少是饮用水标准 ;Principles (2) Potential for microbial growth Systems must be properly validated Wa