(仅供参考)制药厂设备维护部门经常发生的十个GMP问题

白皮书：制药厂设备维护部门经常发生的十个 GMP 问题
小编按：本白皮书列举了十个药厂设备维护部门最常发生的 GMP 合规性问题。在检察官进行现场检查 时，这十个问题经常给企业带来很大的麻烦。建议您在检察官下次进行检查之前，预先找出这些问题， 并展开调查，尽早将问题先行解决。
问题一 A risk-based approach to maintenance is not used
We recommend a simple four-category system for equipment: 我们建议将设备分为了四类： 1. Direct Impact (Product Critical Equipment)直接影响（关键设备）
关键设备是指直接影响产品质量的设备。例如：冻干机 2. Indirect Imp来自百度文库ct (Process / System Critical Equipment) 间接影响（工艺/系统关键设备）
Validation should be included in the budget for any CMMS. When using a risk-based approach to validation, you need to validate only the five GMP-critical tasks listed above– not the whole system. An unvalidated CMMS is not defendable during an audit, so if you can’t afford validation you may as well forget the whole thing. 在规划 CMMS 项目时，一定要包括计算机系统验证的预算。如果使用基于风险的方法实施计算机系统验 证，只需要验证 CMMS 系统的上述五项 GMP 重要功能及其他 GMP 相关功能，而不一定是验证整个 CMMS 系统。在检查时，没有被计算机系统验证过的 CMMS 是没有合理性与说服力的，如果你无法保证 CMMS 系统能被合理的验证过，也许就不该考虑实施 CMMS 系统。
工艺/系统关键设备是指对工艺或系统性能有间接影响的设备，这些设备的故障可能影响成品的质量 或安全。例如：高压灭菌器内的温度监控器 3. No Impact Equipment 无影响 这些设备是指对最终产品质量、安全或环境没有影响的设备。例如：厂房入口处的安全水栅门。 4. Safety/Environmental Impact System 安全/环境影响系统 这类设备是指对安全或环境有直接影响的设备。例如：锅炉。
在维护工作中没有使用基于风险的方法
It's common to treat every piece of equipment within a pharma plant equally when it comes to maintenance. A better way is to use a risk-based approach that classifies each piece of equipment in terms of its impact on product quality. 在药厂中，通常所有设备接受的都是同等维护。但是，更好的方法是使用基于风险的方法，根据每个设 备对产品质量的影响，对设备的维护进行划分。
This categorization system is detailed in the ISPE Baseline Guideline on Qualification and Commissioning, Volume 5, Impact Assessment. The Direct, Indirect, No Impact and Safety categories are sometimes referred to as the D.I.N.S. system. 设备的这种分类体系在国际制药工程协会的《确认和调试基本指南》中第五卷“影响评估”中有详细说 明。上述设备的四种分类体系也简称为 D.I.N.S.体系。
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问题 4 Maintenance staff and contractors are not trained properly
维护人员和维护承包商没有接受适当培训
Do your maintenance workers and contractors know the impact of changing a setting on a piece of production equipment? Do they understand the concept of a validated state? Do they know when to involve QA? 维护人员和维护承包商是否知道变更生产设备的某个设置会造成什么影响？他们是否理解已验证状态的 意义？什么时候需要 QA 参与？
2. Describing the validated plant configuration 说明已验证厂房布局
3. Being the repository of maintenance plans 汇总维护计划
4. Holding records of maintenance activities 保存维护活动的记录
A CMMS typically performs five GMP-critical tasks: 信息化设备维护管理系统 CMMS 通常执行下列五项重要的 GMP 工作：
1. Allocating a Unique Identifying Number(UINs) to each piece of equipment 为每个设备分配独一无二的标识码（UINs）
问题二 Computerized Maintenance Management Systems (CMMS) are not utilized, are under-utilized or are not
validated 没有使用信息化的设备维护管理系统（CMMS），或使用程度不足，或 CMMS 系统未验证
Whenever hybrid system exists, the computer system gets preference because it’s easier. Paper systems are neglected and maintenance job sheets get lost. An auditor will target this area because it’s often difficult for companies to get right. Our advice? Use a validated CMMS system. 计算机系统在混合管理系统中更受青睐，因为这样会使工作便捷，纸质系统往往被忽略，维护工作单会 丢失。检察官检查的重点也在此，因为企业往往会犯错误。我们的建议是使用已验证的全信息化的 CMMS 系统。
Using a risk-based approach such as DINS can dramatically impact the amount of work facing a maintenance department. For example, your maintenance schedule may require that all temperature transmitters be calibrated annually. This is the same frequency for an autoclave as for the ambient air temperature measurement in a warehouse. Which one is more likely to impact product quality? The frequency of calibration should be determined during the validation or re-validation project phases. Using the risk-based categorization approach, the temperature transmitter in the autoclave may need calibration every three months, but the warehouse temperature transmitter may need calibration only once every two years. 采用这种基于风险的方法，例如 DINS，可以显著减少维修部门的工作量。例如：维修计划可能要求所有 温度传感器每年都要进行校准。也就是说高温灭菌器中的传感器和仓库环境空气温度测量器中的传感器 校验周期相同。究竟哪个传感器对产品质量的影响更大呢？校验周期应在验证或复验阶段规定。根据基 于风险的方法，高温灭菌器中的传感器需要每三个月校验一次，而仓库温度传感器只需要两年校验一 下。
5. Scheduling maintenance activities
安排维护活动
As consultants to the industry, we often see hybrid management systems within maintenance departments. 作为顾问，我们通常会发现企业维护部门使用的是混合管理系统（纸质管理系统和计算机系统）。
These hybrid systems may keep the UIN list in a spreadsheet, store the plans and records as paper files and schedule maintenance activities with a computer system. 这样的混合管理系统就是把 UIN 清单转化为电子表格，把计划和记录保存为纸质文件，用计算机系统安 排维护活动。
Let’s face it –maintenance staff would rather watch 15 hours of snail racing on TV than complete paperwork. It’s hard enough to get them to complete maintenance records, let alone Change Control forms. Yet simple maintenance activities such as changing filters or adding lubricant can dramatically impact product quality. 事实上，维护人员更愿意看 15 个小时的蜗牛赛跑节目，而不是完成纸质文件。维护人员很难完成维护记 录，更不用说变更控制表单了。然而简单的维护工作，例如换装过滤器或添加润滑油，都可能对产品质 量造成很大影响。
问题三 Maintenance plans are not updated as part of new equipment introduction
新设备进厂后，维护计划没有更新
Buying a new piece of hi-tech machinery is very exciting. All the engineers scramble to be the first one to stroke its gleaming steel. Amongst all that excitement, the fact that this newbie has to be maintained is often neglected. Updating the maintenance plan should be included as an activity in the procedure covering new equipment installation. 购置新的高端设备是令人兴奋的，所有工程师都想成为第一个使用的人。但是在兴奋之中，新设备的维 护却往往被忽略。如果购置安装了新设备，需要更新维护计划。