旧车间版GMP改造风险评估[概述].docVIP

车间2010版GMP改造 风险评估（概述） 目的： 根据中国《药品生产质量管理规范（2010年修订）》污染、交叉污染以及混淆、差错等风险生产工艺流程空气洁净级别布局。。严重影响高 中等 低 没影响 不可能生产区和贮存区应当有足够的空间洁净区与非洁净区之间、不同级别洁净区之间的压差应当不低于10帕斯卡防鼠虫设施鼠 水池地漏排水设施材质符合洁净要求； 排水有气隔断，设计合理 3. AB级区不得有地漏水池； 11 照明通讯门禁互锁等厂房设施 室内照度符合要求； 室内照明设施安装外检修式 设施等安装要与顶棚或墙面平齐，采用嵌入式安装； 有应急照明、安全疏散设施； 门禁互锁可以满足门的联锁要求和限制人员进出要求。 12 厂房防爆性能 防爆区设计合理 防火区域装饰材料符合要求； 有爆炸危险的区域有足够的泄压面积； 有安全疏散及安全出口； 13 EHS风险 有毒有害的作业环境有防护设施； 易产尘的操作有除尘措施； 废气、废水、废物的处理符合要求； 请：仔细对照GMP2010版每一条款要求进行补充。 请：仔细对照相关剂型的附录要求进行补充。 2、设备部分风险评估（略） 3、物料管理与仓储区域风险评估（略） 4、生产管理与工艺过程风险评估（略） 说明： 风险评估主要从以下几方面详述： GMP法规条款要求的详细对照 具体的工艺要求及各工序防治污染与交叉污染措施 列明法规要求 详述现状与存在的风险 风险等级可以不打分直接分级 应采取的控制与改造措施详述 拟采取措施后的风险再评估，是否可以接受 根据改造的难易程度，判断改造的可行性 风险评估结论 风险评估综述 需改造项清单 改造的可行性 of the contract must be /; Seven or one copy of the contract, each contract form, contents and elements; VIII, master/slave contract and complete specification interface, contract number. 5.9 other provisions the Bank supports risk managers, accompanied by professional risk management, such as account managers handle the pre-loan investigation, contracts and other key sectors. Risk managers and other professional accompanied by risk managers, account managers are still subject to these measures (procedures) for the fulfilment of duties, qilu Bank risk managers, risk managers, in accordance with the administrative procedures (trial implementation) called for duties. Risk management risk managers and other professional personnel involved in handling, account manager with double handle. 6. the credit policy of the Bank to support capital uses reasonable and sufficient source of repayment, parties of good credit personal loans. As described in the Banks credit policy, marketing advice, business management and other documents. 7. process description and control business processes including personal loans loan application, acceptance and investigation, risk assessment and review, loan approval, Contracting, loan origination, loan payments, credit administration an