预防性维护

厌氧菌1

求国内外关于预防性维护的法规要求

alvinqiyuan

Topic主题        21 CFR Part 211 (cGMP) Citations
21CFR 211（cGMP）引述        Maintenance Good Practices
良好维护规范
Organization
and Personnel
组织和人员        §211.25 Personnel Qualifiations.
§211.25 人员和资质
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.
每个参与生产，加工，包装或药品保存的人员应当具备教育，培训和经验或者任何组合，使得该人员能够执行分配的职能。
Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations), as they relate to the employee’s performed functions.
培训应当在员工执行的特定操作中和cGMP中进行（包括本章中的cGMP法规以及法规要求的书面规程），因为这些操作和法规与员工所执行的职能有关。
Training in current good manufacturing practice shall be conducted by qualifid individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.
在cGMP中的培训应当由有资质的人员在持续的基础上，以充分的频次，确保员工持续熟悉适适用于他们的cGMP要求。
§211.34 Consultants顾问
Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subiect for which they are retained.
对生产，加工，包装和药品存储提出建议的顾问应当具备充分的教育，培训，和经验或者任何组合，就他们熟知的课题提出建议。
Records shall be maintained stating the name, address, and qualifications of any consultants and the type of services they provide
应当保留记录，指明所有顾问的名字，地址和资质，以及他们提供的类型。        General cGMP training and job specific cGMP training must be performed.
必须执行通用cGMP培训和具体工作相关的cGMP培训。
CGMP Training should ensure that maintenance persons understand how their work impacts or might impact drug product quality.
cGMP培训应当确保维护人员理解其工作如何影响或可能如何影响产品质量。

A cGMP training curriculum should be in place for all maintenance staff.
应当为所有维护人员制定cGMP培训课程表。
Training should be documented with sufficient frequency.
培训应当有充分频次的文件记录。
A process to ensure qualifiations of individuals performing maintenance activities should be in place.
应当建立流程确保有资质的人员执行维护活动。
Contractors performing maintenance activities are subject to the same requirements as internal resources.
对执行维护活动的承包商的要求与对内部人员的要求相同。
“Consultants” refers to those who advise maintenance organizations and is not intended to include contractors who perform maintenance
“顾问”指的是那些对维护组织提出建议的人员，且无意包括执行维护的承包商。
Buildings and
Facilities
建筑和设施

        §211.42 Design and construction features.
§211.42 设计和建筑特征
(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.
药品的生产，加工，包装或保存的建筑或建筑群应当具有适当的规模，建筑，和位置，以便清洁，维护和适当的操作。

(c) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm’s operations as are necessary to prevent contamination or mix-ups during the course of the following procedures:
应当在适当大小的特殊规定区域内执行操作。
公司的操作应当具有必要的独立地或规定区域或类似的其他控制系统，以防止以下程序过程中的污染或混淆：
(10) Aseptic processing, which includes as appropriate: Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable;
无菌加工，视情况而定包括:容易清洁的光滑坚硬的地面，墙面，和天花板。
Temperature and humidity controls;
温度和湿度控制
An air supply filtered through high-efficiency particulate air fiters under positive pressure, regardless of whether flow is laminar or non-laminar; A system for monitoring environmental conditions;
通过HEPA过滤器在正压下送风，无论是层流还是非层流；用于监测环境条件的系统；
A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
房间和设备清洁和消毒系统，用于创建无菌条件。
A system for maintaining any equipment used to control the aseptic conditions.
维持所有用于控制无菌条件的设备的系统。

§211.58 Maintenance.维护
Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.
所有用于药品生产，加工，包装或保存的建筑应当维持良好的维修状态。        cGMP facilities design and equipment layout must consider maintenance activities, and therefore, it would be expected that the Maintenance Unit is involved in the design review of facilities.
cGMP设施设计和设备布局必须考虑维护活动，而且因此，期望维护单元参与设施设计审核。
Maintenance activities should be controlled to prevent contamination.
维护活动应当受控以防止污染。



Inspections of facilities, buildings, and building systems should be performed and documented. When inspections identify deficiencies, they should be corrected expeditiously
应当对设施，建筑，和建筑系统进行检查并有文件记录。如果检查发现缺陷，应当立即对这些缺陷进行整改。



Equipment设备

        §211.63 Equipment design, size, and location
§211.63设备设计，大小和位置
Equipment used in the manufacture, processing，packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended used and for its cleaning and maintenance
用于药品生产，加工，包装或保存的设备应当设计得当，大小适合，并位置适当以有利于其预期用途的操作和清洁维护。
§211.65 Equipment construction
b)Any substances required for operation, such as lubricants or coolants，shall not come into contact with components, drug product containers,closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality,or purity of the drug beyond the official or other established requirements
§211.65 设备建造
b)所有操作所需要的物质，如润滑剂或冷却剂不得直接接触组分，药品容器，密封件，中间体，或药品，避免改变药品的安全性，鉴别，效价，质量或纯度，超出官方的或其他规定的要求。        The Maintenance Unit should be involved at appropriate points in the equipment specification, procurement,and deployment processes
维护单元应当在设备设计，采购和部署过程中适当阶段参与。





Materials used in performance of maintenance activities should be evaluated for their potential impact on product prior to use
应当在使用前评估维护活动执行中所使用的物料对产品的潜在影响。

        §211.67 Equipment cleaning and maintenance.
§211.67 设备清洁和维护
Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the offiial or other established requirements.
应当对设备和器具以适当的周期进行清洁，维护和消毒，以防止故障或污染，这些故障和污染可能改变药品的安全性，鉴别，效价，质量或纯度，超出官方的或其他规定的要求。
Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but
are not necessarily limited to, the following:
药品生产，加工，包装或保存中所使用的设备，包括器具的清洁和维护，应当建立并遵循书面程序。这些程序应当包括，但不限于，以下：
Assignment of responsibility for cleaning and maintaining equipment;
分配器具和维护设备的职责。
Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.
维护和清洁日程安排，包括，适当时，消毒日程安排。
A description in sufficient detail of methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.
充分详细的描述用于清洁和维护操作所使用的方法，设备，和物料，以及必要的拆卸和组装设备的方法，确保适当适当的清洁和维护。
Removal or obliteration of previous batch identifiation;
移除或删除之前批次标识；
Protection of clean equipment from contamination prior to use;
防止使用前污染已清洁的设备；
Inspection of equipment for cleanliness immediately before use.
使用前立即检查设备洁净度。
Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specifid in §211.180 and §211.182.
应当按照§211.180 和§211.182要求保留维护，清洁，消毒和检查的记录。

§211.68 Automatic, mechanical, and electronic equipment自动，机械和电子设备
(a )Automatic, mechanical, or electronic equipment or other types of equipment, including computers or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product.
(a )能够可靠地完成某功能的自动，机械，或电子设备或其他类型的设备，包括计算机或相关系统，可用于药品的生产，加工，包装和存储。
If such equipment is so used it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained
如果此类设备如此使用，该设备应当定期校准，视察，或按照书面程检查，以确保适当的性能。应当保留这些校准检查和视察的书面记录。        Maintenance should be performed on equipment and systems to ensure its required performance.
应当对设备和系统执行维护以确保维持其要求的性能。

In addition, maintenance should be performed in a way so as to assure there is no impact to the product, such as contamination.
此外，执行维护的方式应当确保不会对产品造成影响，如污染。

Preventive Maintenance plans should be in writing.
预防性维护计划应当是书面的。
Plans should be sufficiently detailed to ensure the range of skilled and trained persons called upon can properly execute the work. The work should follow a predetermined schedule and should be documented.
计划应当充分详细以确保召集的不同层次的熟练的和经过培训的人员能够适当执行工作。工作应当遵循预定日程表而且应当有文件记录。


CMMSs should be evaluated for their impact on product quality.
应当评估CMMSs对产品质量的影响。
Systems that are used for scheduling or recording the work should be evaluated to determine whether and to what extent commissioning, software validation, or hardware qualifiation are applicable.
应当对用于制定进度和记录工作的系统进行评估，以判断是否以及应用何种程度的调试，软件验证或硬件确认。

Maintenance programs solely relying on electronic data should be 21 CFR Part 11 compliant.
仅仅依靠电子数据的维护程序应当符合21CFR 11部分要求。
Production
and Process
Controls
生产和工艺控制        §211.100 Written procedures; deviations.
§211.100 书面程序；偏差
(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity， strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the Quality Unit.
应当有书面的生产和过程控制程序，旨在确保药品具有其所宣称或代表具备的的鉴别，效价，质量和纯度。此类程序应当包括该子小节所有的要求。这些书面程序，包括所有变更，应当由适当的组织单元起草，审核，并批准，并由质量单元审核并批准。
(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
在执行多种生产和工艺控制功能时应当遵循书面的生产和工艺控制程序，而且应当在执行时有文件记录。任何偏离书面程序的情况都应有书面记录并说明理由。
§211.105 Equipment identifiation.设备标识
(b) Major equipment shall be identified by a distinctive identifiation number or code that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product.
（b）主要设备应当由独特的识别号或代码识别，而且这些识别号或代码应当记录在批生产记录中以显示每个批次药品生成中使用的具体设备。
In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code.
如果某生产设施内只有只有一种特定类型的设备，可以使用设备名称替代独特的识别号或代码。       


Change management procedures should be in place to assess and approve equipment/component changes performed during maintenance that may have an impact on product quality.
应当制定变更管理程序以评估和批准在维护中执行的可能对产品质量有影响的设备/部件变更。
Changes made to maintenance processes or procedures need to be properly reviewed and documented. Any observations noted on WOs should be reviewed and acted upon accordingly.
cGMP components or systems should be identified and should have a unique identifiation number.
需要适当审核和记录维护流程或规程中发生的变更。应当审核所有记录在WOs中的异常事项并据此采取行动。
应当识别cGMP部件或系统，而且应当有唯一的识别号。
Records and
Reports
记录和报告        §211.182 Equipment cleaning and use log.
§211.182 设备清洁和使用日志
A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed.
每台设备的日志应当包括主要设备的清洁，维护（除日常维护，如润滑和微调）和使用的书面记录，并显示加工的每个批次的日期，时间，产品和批号。
If equipment is dedicated to manufacture one product, individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence.
如果设备专门生产一种产品，则不需要单独的设备日志，前提是此类产品的批号或批次遵循流水号，并按照流水号顺序生产。
In cases where dedicated equipment is employed, the records of cleaning and maintenance and use shall be part of the batch record.
如果使用专用设备，清洁和维护和使用记录应当作为批记录的一部分。
The persons performing and double-checking the cleaning and maintenance shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
清洁和维护的执行人员和双人复核人员应当在日志上签字日期或签首字母，显示工作已完成。日志上的输入栏位应当按时间顺序。        When maintenance is being performed and equipment, systems, or an area is out of service, this should be clearly indicated.
如果正在执行维护，以及设备，系统或区域停用，应当明确标明。

Major cGMP equipment should be identified and the maintenance performed should be recorded.
应当识别主要cGMP设备，且记录所执行的维护活动。
An appropriate verification of the maintenance work also should be performed.
还应当对维护工作执行适当的确认。
Recording routine and non-routine maintenance in the same manner is recommended, as this facilitates documentation, reporting, and investigation.
建议以同样的方式执行常规和非常规的维护，因为这有利于文档，报告和调查。

来自ISPE，仅供参考。

厌氧菌1

alvinqiyuan 发表于 2020-7-10 16:48
Topic主题        21 CFR Part 211 (cGMP) Citations
21CFR 211（cGMP）引述        Maintenance Good Practices
良好维 ...

感谢感谢感谢

jedi271

ISPE基准指南第八卷维护，里面讲得还挺好的，可以参考下。

小金库

感谢分享。