《药品生产企业实施药品(GMP2010)年修订.doc》由会员分享，可在线阅读，更多相关《药品生产企业实施药品(GMP2010)年修订.doc（14页珍藏版）》请在金锄头文库上搜索。
1、关于组织全区抗艾滋病、结核病及疟疾类药品生产企业填报调查问卷的函附件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)1. 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
2、 in the frame of the implementation of the Chinese GMP Guidelines (revised in 2010)?a. 以风险为基础的质量保证体系 Risk based quality assurance systemb. 质量受权人和其他关键人员 Qualified person and other key personsc. 人员培训 Personnel Trainingd. 文件体系 Documentation systeme. 空调净化系统 HVAC system f. 工艺用水制备 Process water preparatio
3、n g. 设备的校准，确认和预防性维护 Equipment calibration, qualification, and preventive maintenanceh. 工艺验证 Process validationi. 清洁验证Cleaning validationj. 产品质量回顾 Product quality reviewk. 库房Warehouse l. 供应商确认 Supplier qualification m. 委托生产，委托检验 Contract manufacturing / testingn. 质控实验室QC laboratory o. 偏差、纠正与预防措施Devia
4、tion / CAPAp. 超标检验数据调查OOS investigationsq. 变更控制Change control2. 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 Marketin
5、g Authorization?a. 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?b. 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 (Val
6、idation Master Plan)?c. 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?d. 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 pr
7、ocedure?3. 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.)?a. 质量保证或质量受权人员在质量事务和成品批放行方面，有独立决策权吗？Is there an i
8、ndependence of quality assurance / Qualified Person in making decision of quality matters and batch release of finished products?b. 在法规事务、检验技术和生产技术方面，对质量受权人和其他关键人员有持续性的培训吗？Do the Qualified Person and other key persons receive continuous training in regulatory affairs and in analytical and production
9、 technology?c. 相关人员在岗位说明书上签字了吗?Are the job descriptions signed by the people concerned? d. 现场是否有：组织机构图、岗位说明书（质量受权人、质量保证部经理、质量控制部经理和生产部经理）、成品批放行程序。Documents to be provided: organization diagram, job descriptions for QP, QA, QC and production managers, batch release procedure for finished products. 4.
10、 您是否根据药品GMP（2010年修订）的要求适当组织了培训？Do you organize training properly according to the GMP Guidelines (revised in 2010)?a. 您的培训工作中包括入职培训、药品GMP持续性培训、岗位操作培训以及关于标准操作规程的培训吗？Does your training program include introduction training, continuous GMP training, on-the-job training, and training on SOPs?b. 您对培训需求是怎
11、样定义的（范围、内容、参加人员、时间安排）？How do you define your training needs (scope, content, involved persons, time arrangement)?c. 培训计划的起草和批准程序是怎样的？谁来组织和监督培训（工作）？对于那些偏离（培训）日程计划的情形，是否有报告制度？What is your procedure for preparing and approving the training plan? Who is organizing and supervising the training? Is there
12、a system to report the deviations from the planned schedule?d. 您的药品GMP培训计划中是否包括了您公司不直接参与生产、质控或质保的高层管理者，譬如总经理、采购部（经理）等？Are the top managers of your company, not directly involved in production and quality control/assurance such as general manager, purchasing, etc. included in your GMP training plan?e
13、. 培训师需要具备哪些资质？您是如何管理（公司）内部培训师的？您定期对他们进行适当培训吗？What are the qualifications of trainers? How do you manage the internal trainers? Do they get proper training regularly?f. 您是如何管理培训记录的？您如何评估培训效果？How do you manage your training records and evaluate training effectiveness?5. 您是否建立了清晰明确的药品GMP文件体系？Do you est
14、ablish a well-organized GMP documentation system?a. 您公司把哪些类文件视为药品GMP文件？请列表说明。What types of documents are considered as GMP documentation in your company? Please make a list.b. 您公司一共有多少份标准操作规程？您有关于制定这类文件的标准程序吗？How many SOPs do you have in your company? Do you have an SOP for SOPs?c. 谁来起草、签署、发放文件母本（即原
15、件）？您是如何保存那些原件的？Who is preparing, signing and issuing the master (i.e. original) documents? How do you store them? d. 您如何准备、发放那些工作（现场）用的文件？How do you prepare and issue the working documents?e. 文件变更控制体系程序是怎样的？What is the procedure for change control system for the documentation?f. 当（文件）发生变更时，您是如何确保所有人都得到并且在工作中使用最新版本？When changes occur, how do you ensure that everyone has got and worked with the latest version?g. 您的各个文件之间有交叉引用信息吗?Do your documents have a cross-reference to other documents?h. 您文件的回顾性审查程序是怎样的？回顾审核的周期是多久？What is your document reviewing proce
