发布时间 : 星期一 文章ICH-Q9质量风险管理更新完毕开始阅读ec10749077eeaeaad1f34693daef5ef7bb0d1261
Quality Risk Management/质量风险管理
变更管理/ 变更控制
To manage changes based on knowledge and information accumulated in pharmaceutical development and during manufacturing;
在药品开发和生产过程中的知识与信息基础上进行变更管理； To evaluate the impact of the changes on the availability of the final product; 对变更造成可能的最终产品的影响进行评价；
To evaluate the impact on product quality of changes to the facility, equipment, material, manufacturing process or technical transfers;
对厂房，设备，物料，制造工艺或执行的技术转移的变更对产品质量的影响进行评价；
To determine appropriate actions preceding the implementation of a change, e.g., additional testing, (re)qualification, (re)validation or communication with regulators. 确定在变更之前要采取的措施，如另外的检测，(再)定性，(再)验证，与管理者沟通。
Continual improvement 持续改进
To facilitate continual improvement in processes throughout the product lifecycle. 贯穿产品生命周期的全部过程的公共设施持续改进。
II.2 Quality Risk Management as Part of Regulatory Operations 药政操作部分的质量风险管理
Inspection and assessment activities 检查与评估活动
To assist with resource allocation including, for example, inspection planning and frequency, and inspection and assessment intensity (see \II.1);
促进资源分配包括，例如，检查计划，频率和强度(见附录 II.1 中的“审计”部分)； To evaluate the significance of, for example, quality defects, potential recalls and inspectional findings;
评估其有效性，例如，质量缺陷，可能的召回以及检查发现；
To determine the appropriateness and type of post-inspection regulatory follow-up; 确定适当性以及检查后的管理类型；
To evaluate information submitted by industry including pharmaceutical development information;
翻译：徐禾丰
29
Quality Risk Management/质量风险管理
有系统地评估由业界递交的信息，包括药品开发信息； To evaluate impact of proposed variations or changes; 评估所计划的变更或更改造成的影响；
To identify risks which should be communicated between inspectors and assessors to facilitate better understanding of how risks can be or are controlled (e.g., parametric release, Process Analytical Technology (PAT)).
辨识哪些风险是应当要让检查官和评审官共享的，以更好地理解如何控制风险和/或进行某次检查的需要(比如：参数放行，工艺过程分析技术(PAT))。 II.3 Quality Risk Management as Part of development 开发部分的质量风险管理 To design a quality product and its manufacturing process to consistently deliver the intended performance of the product (see ICH Q8);
设计产品质量以及其制造工艺以便一贯地传递产品预期的性能(见 ICH Q8)； To enhance knowledge of product performance over a wide range of material attributes (e.g., particle size distribution, moisture content, flow properties), processing options and process parameters;
加强对产品的更宽范围的物料性质(如，质粒大小分布，含水量，流动性)，工艺操作以及工艺参数等的了解；
To assess the critical attributes of raw materials, solvents, Active Pharmaceutical Ingredient (API) starting materials, APIs, excipients, or packaging materials; 对原材料，溶剂，活性药物中间体(API)-起始原料，API 本身的，赋形剂或包材的关键性质进行估计；
To establish appropriate specifications, identify critical process parameters and establish manufacturing controls (e.g., using information from pharmaceutical development studies regarding the clinical significance of quality attributes and the ability to control them during processing);
建立适当的规格标准，辨识关键的工艺参数以及建立制造控制(如，运用从药品开发研究得到的关于质量属性的临床显著性，以及在生产工艺中控制它们的能力的信息)；
To decrease variability of quality attributes: 为了减少质量性质的变异： ? reduce product and material defects; 减少产品及物料的缺陷； ? reduce manufacturing defects. 减少生产缺陷；
To assess the need for additional studies (e.g., bioequivalence, stability) relating to scale up and technology transfer;
评估与放大和技术转移有关的额外的研究的需要(如生物等效性，稳定性)； To make use of the “design space” concept (see ICH Q8).
翻译：徐禾丰
30
Quality Risk Management/质量风险管理
使用“设计空间”的概念(见 ICH Q8)。
II.4 Quality Risk Management for Facilities, Equipment and Utilities厂房，设备和公用设施的质量风险管理 Design of facility / equipment 厂房/ 设备的设计
To determine appropriate zones when designing buildings and facilities, e.g., 当设计如建筑和厂房时，为了确定合适的地方，例如， ? flow of material and personnel; 物流和人流； ? minimize contamination; 使污染最小化； ? pest control measures; 害虫控制措施； ? prevention of mix-ups; 避免混淆；
? open versus closed equipment; 开放相对于密闭设备；
? clean rooms versus isolator technologies; 洁净室相对于隔离技术； ? dedicated or segregated facilities / equipment. 专用或隔离的设施/设备。 To determine appropriate product contact materials for equipment and containers (e.g., selection of stainless steel grade, gaskets, lubricants);
为了确定与产品接触的合适的设备和包装的物料(如不锈钢级别，垫圈，润滑剂的选择)；
To determine appropriate utilities (e.g., steam, gases, power source, compressed air, heating, ventilation and air conditioning (HVAC), water);
确定合适的公用设施(如，蒸汽，气体，能源，压缩空气，加热，空调系统(HVAC)，水)；
To determine appropriate preventive maintenance for associated equipment (e.g., inventory of necessary spare parts).
对于关联的设备确定合适的预防性维修(如所需要的必须的备用部件清单)。 Hygiene aspects in facilities 设施的卫生状况
To protect the product from environmental hazards, including chemical,
microbiological, and physical hazards (e.g., determining appropriate clothing and gowning, hygiene concerns);
保护产品免受环境伤害，包括化学的，微生物的，物理伤害(如，确定合适的衣服和长衣，卫生相关的)；
翻译：徐禾丰
31
Quality Risk Management/质量风险管理
To protect the environment (e.g., personnel, potential for cross-contamination) from hazards related to the product being manufactured.
保护环境(如人员，潜在的交叉污染)免受到所生产的产品造成的相关伤害。 Qualification of facility/equipment/utilities 厂房/ 设备/ 设施的确认
To determine the scope and extent of qualification of facilities, buildings, and production equipment and/or laboratory instruments (including proper calibration methods).
确定厂房，建筑，生产设备以及/或实验室仪器(包括适当的校正方法)的确认的范围和广度。
Cleaning of equipment and environmental control 设备清洁以及环境控制
To differentiate efforts and decisions based on the intended use (e.g., multi- versus single-purpose, batch versus continuous production);
在目标使用的基础上区分影响和决策(如，多相对于单个，批相对于连续生产)； To determine acceptable (specified) cleaning validation limits. 确定可接受的清洁验证限度。 Calibration/preventive maintenance 校正/ 预防性维修
To set appropriate calibration and maintenance schedules. 设立合适的校正及维修时间表。
Computer systems and computer controlled equipment 计算机系统以及计算机控制设备
To select the design of computer hardware and software (e.g., modular, structured, fault tolerance);
选择计算机硬件和软件的设计方案(如，模块，结构，故障耐受性)； To determine the extent of validation, e.g., 确定验证的广度，如
? identification of critical performance parameters; 辨识关键操作参数； ? selection of the requirements and design; 要求与设计的选择； ? code review; 代码评审；
翻译：徐禾丰
32