GMP(2010修订)过程中存在差距的调查问.docVIP

药品生产企业实施药品GMP（2010年修订） 过程中存在差距的调查问卷 Questionnaire for Investigation of the Gaps of Pharmaceutical Enterprises in Relation to the GMP Guidelines (revised in 2010) 在中国药品GMP（2010年修订）的总体实施层面，您主要欠缺哪些知识，有哪些培训需求？ What are your major knowledge shortages and need for training in the frame of the implementation of the Chinese GMP Guidelines (revised in 2010)? 以风险为基础的质量保证体系 Risk based quality assurance system 质量受权人和其他关键人员 Qualified person and other key persons 人员培训 Personnel Training 文件体系 Documentation system 空调净化系统 HVAC system 工艺用水制备 Process water preparation 设备的校准，确认和预防性维护 Equipment calibration, qualification, and preventive maintenance 工艺验证 Process validation 清洁验证 Cleaning validation 产品质量回顾 Product quality review 库房 Warehouse 供应商确认 Supplier qualification 委托生产，委托检验 Contract manufacturing / testing 质控实验室 QC laboratory 偏差、纠正与预防措施 Deviation / CAPA 超标检验数据调查 OOS investigations 变更控制 Change control 您所建立的质量保证体系是否以确保产品安全并且符合注册批准要求为目的，以科学为准则并且以风险管理为基础？ Is your quality assurance system established on scientific principles and on risk management basis to ensure that your products are safe and comply with the requirements of the Marketing Authorization? 您的质量保证体系把那些可能影响产品质量的关键参数考虑在内了吗？ Does your quality assurance system consider critical parameters that may impact on product quality? 那些关键参数及其控制范围是通过风险评估确定的吗？它们包含在验证总计划中了吗？ Are those critical parameters and their control ranges defined by risk assessment and included in the VMP (Validation Master Plan)? 您有用于确定那些参数及其范围的系统性方法吗，譬如“失效模式影响分析”？ Is there a systematic approach such as FMEA (Failure Mode Effect Analysis) to define those parameters and ranges? 您公司有风险评估的书面程序吗，尤其是（相关的）决策程序？ Does your company have a written risk assessment procedure, especially for the decision making procedure? 对于质量受权人和其他关键人员（生产、质控、质保、仓储、工程等），您是否系统地制定了清晰明确的岗位说明？ Have you established a well-defined job description system for Qualified Persons (QP) and other key persons (production, quality control, quality assurance, warehousing, engineering, etc