美国FDA 医疗器械体系法规QSR820中英文对照(六)

Subpart G--Production and Process Controls生产和工艺控制 Sec. 820.70 Production and process controls.生产和工艺控制 (a)

Subpart G--Production and Process Controls生产和工艺控制

Sec. 820.70 Production and process controls.生产和工艺控制

(a) General. Each manufacturer shall develop, conduct,control, and monitor production processes to ensure that a device conforms toits specifications. Where deviations from device specifications could occur asa result of the manufacturing process, the manufacturer shall establish andmaintain process control procedures that describe any process controlsnecessary to ensure conformance to specifications. Where process controls areneeded they shall include:

    a)概述。制造商应当开发、实施、控制和监控生产工艺来保证器械符合其标准。在制造过程中可能会出现偏离标准的偏差,制造商应当建立和维护描述了必要工艺控制的工艺控制规程来保证符合标准要求。工艺控制应包括如下内容:

(1) Documented instructions, standard operatingprocedures (SOP's), and methods that define and control the manner ofproduction;

    1)文件化的指导书、标准操作规程、以及界定和控制生产方式的方法;

(2) Monitoring and control of process parameters andcomponent and device characteristics during production;

    2)在生产期间对器械特性、组件、工艺参数的监控和控制;

(3) Compliance with specified reference standards orcodes;

    3)符合特定的标准和法规;

(4) The approval of processes and process equipment; and

    4)工艺和工艺设备的确认;和

(5) Criteria for workmanship which shall be expressed indocumented standards or by means of identified and approved representativesamples.

    5标准的工艺,应在文件化的标准中加以明确或通过确定好的和确认过的样件方式进行。

(b) Production and process changes. Each manufacturershall establish and maintain procedures for changes to a specification, method,process, or procedure. Such changes shall be verified or where appropriatevalidated according to 820.75, before implementation and these activities shallbe documented. Changes shall be approved in accordance with 820.40.

    b)生产和工艺的变更。制造商应当建立和维护一个用一于标准、方法、工艺、规程的变更规程。变更在其实施前应当依据820.75经过适当的确认和验证。这些措施应当予以记录。变更应当依据820.40的要求经过批准。

(c) Environmental control. Where environmentalconditions could reasonably be expected to have an adverse effect on productquality, the manufacturer shall establish and maintain procedures to adequatelycontrol these environmental conditions. Environmental control system(s) shallbe periodically inspected to verify that the system, including necessaryequipment, is adequate and functioning properly. These activities shall bedocumented and reviewed.

    c)环境控制。如果环境条件可能对产品质量有不利影响时,制造商应当建立和维护充分的控制这些环境的规程。应当定期的、对环境控制系统进行检查来保证包括必要设备的系统处于良好的工作状态。这些措施应当予以记录和审核。

(d) Personnel. Each manufacturer shall establish andmaintain requirements for the health, cleanliness, personal practices, andclothing of personnel if contact between such personnel and product orenvironment could reasonably be expected to have an adverse effect on productquality. The manufacturer shall ensure that maintenance and other personnel whoare required to work temporarily under special environmental conditions areappropriately trained or supervised by a trained individual.

ect on product quality.

    d)人员。如果人和环境或产品接触会直接影响产品质量。那么制造商应当建立和维护用于健康,卫生,人员操作和人员着装有关的要求。并保证维修人员及其他工作在有要求的特定环境下的人员经过适当的培训和考核。

(e) Contamination control. Each manufacturer shallestablish and maintain procedures to prevent contamination of equipment orproduct by substances that could reasonably be expected to have an adverseeffect on product quality.

e)污染控制。制造商应当建立和维护防污染的规程来防止对对产品质量有直接影响的物质污染设备和产品。保证所有用于生产工艺的设备符合特定的要求。

(f) Buildings. Buildingsshall be of suitable design and contain sufficient space to perform necessaryoperations, prevent mixups, and assure orderly handling.

    f)建筑。建筑应该当经过适当的设计,拥有足够的空间来实施必要的操作,防止混淆,确保有序操作。

(g) Equipment. Each manufacturer shall ensure that allequipment used in the manufacturing process meets specified requirements and isappropriately designed, constructed, placed, and installed to facilitatemaintenance, adjustment, cleaning, and use.

    g)设备。制造商应当保证所有用于生产工艺的设备符合特定的要求。其设计、操作、放置、安装便于进行维护、维修、清洁和使用。

(1) Maintenance schedule. Each manufacturer shallestablish and maintain schedules for the adjustment, cleaning, and othermaintenance of equipment to ensure that manufacturing specifications are met.Maintenance activities, including the date and individual(s) performing themaintenance activities, shall be documented.

    1)维护保养计划。制造商应当建立和维护用于校准、清洁、或设备的其他维护来保证符合制造标准的要求。包括维护日期和实施维护的人员的维护活动都应当予以记录。

(2) Inspection. Each manufacturer shall conduct periodicinspections in accordance with established procedures to ensure adherence toapplicable equipment maintenance schedules. The inspections, including the dateand individual(s) conducting the inspections, shall be documented.

    2)检查。制造商应当依据所确定的规程实施相应的审核来保证设备维护计划得以实施。包括检查日期和实施检查人员的检查都应当予以记录。

(3) Adjustment.Each manufacturer shall ensure that any inherent limitations or allowabletolerances are visibly posted on or near equipment requiring periodicadjustments or are readily available to personnel performing these adjustments.

    3)校准。组织应确保将规定的限制或允许的误差粘贴在应定期校准的设备上,或放在其附近,或张贴到实施校准工作的人员容易看到的地方。

 

(h) Manufacturing material. Where a manufacturingmaterial could reasonably be expected to have an adverse effect on productquality, the manufacturer shall establish and maintain procedures for the use andremoval of such manufacturing material to ensure that it is removed or limitedto an amount that does not adversely affect the device's quality. The removalor reduction of such manufacturing material shall be documented.

    h)生产原材料。当生产原材料对产品质量有严重影响时,制造商应当建立和维护一个用于使用和去除此种物料的程序从而保证物料被去除或降低到一个不会严重影响器械质量的相应限度。生产原材料的去除和降低应当予以记录。

(i) Automated processes. When computers or automateddata processing systems are used as part of production or the quality system,the manufacturer shall validate computer software for its intended useaccording to an established protocol. All software changes shall be validatedbefore approval and issuance. These validation activities and results shall bedocumented.

    i)自动化工艺。当使用计算机或自动化数据工艺系统作为生产或质量体系统的一部分时,生产商应当依据确定的方案来验证其预期使用的计算机系统软件。在计算机系统变更得到批准和发布前都应当经过验证。验证的活动和结果应当予以记录。

Sec. 820.72 Inspection, measuring, and test equipment.检测、测量和试验设备

(a) Control of inspection, measuring, and testequipment.检测、测量和试验设备控制

 Each manufacturershall ensure that all inspection, measuring, and test equipment, includingmechanical, automated, or electronic inspection and test equipment, is suitablefor its intended purposes and is capable of producing valid results. Eachmanufacturer shall establish and maintain procedures to ensure that equipment isroutinely calibrated, inspected, checked, and maintained. The procedures shallinclude provisions for handling, preservation, and storage of equipment, sothat its accuracy and fitness for use are maintained. These activities shall bedocumented.

    制造商应保证包括手工,自动化或电子的检测和试验设备在内的所有检测、测量和试验设备都符合其预期使用的目的,并且能够得到有效的结果。制造商应当建立和维护一个规程来保证设备经过常规的校准、检验、检查和维护。该程序应当包括设备搬运、保管和存储。以至于其使用的适应性和准确度得以维护。这些活动应当予以记录。

(b) Calibration. Calibration procedures shall includespecific directions and limits for accuracy and precision. When accuracy andprecision limits are not met, there shall be provisions for remedial action toreestablish the limits and to evaluate whether there was any adverse effect onthe device's quality. These activities shall be documented.

    b)校准

    校准程序应当包括准确性和精确度的特定说明和限制。当准确性和精确度的限度无法得到满足时,应该当重新确认该限度并评估是否对器械的质量产生严重的影响。这些活动应当予以记录。

(1) Calibration standards. Calibration standards usedfor inspection, measuring, and test equipment shall be traceable to national orinternational standards. If national or international standards are notpractical or available, the manufacturer shall use an independent reproduciblestandard. If no applicable standard exists, the manufacturer shall establishand maintain an in-house standard.

    1)校准标准

   用于检测、测量和检查试验设备的校准标准应当溯源到国际或国家标准。如果国家或国际标准品不使用或不可用。制造商应使用一个独立的可重现的校准标准。如果没有合适的校准标准,企业应建立和维护一个企业内部标准。

(2) Calibration records. The equipment identification,calibration dates, the individual performing each calibration, and the nextcalibration date shall be documented. These records shall be displayed on ornear each piece of equipment or shall be readily available to the personnelusing such equipment and to the individuals responsible for calibrating theequipment.

    2)校准记录

    设备标识、校准日期、实施校准的人员、下次校准的日期应当予以记录。这些记录应当很容易被使用该设备的人员以及校准该设备的人员观察到。并且应当放置于设备附近,或悬挂于设备上。

Sec. 820.75 Process validation.工艺验证

 

(a) Where the results of a process cannot be fullyverified by subsequent inspection and test, the process shall be validated witha high degree of assurance and approved according to established procedures.The validation activities and results, including the date and signature of theindividual(s) approving the validation and where appropriate the majorequipment validated, shall be documented.

    a)当工艺结果不能通过其后的检验和试验进行充分的确认时,应当用高级别的控制对工艺进行验证。并依据确定的程序来批准该工艺。包括批准验证人员署名和签署日期的在内的验证活动和验证结果以及主要经过了确认的设备,都应当予以记录。

(b) Each manufacturer shall establish and maintainprocedures for monitoring and control of process parameters for validatedprocesses to ensure that the specified requirements continue to be met.

    b)制造商应当建立和维护一个用以监控和控制用于验证过的工艺当中的工艺参数的规程来保证持续符合特定要求。

(1) Each manufacturer shall ensure that validatedprocesses are performed by qualified individual(s).

    1)制造商应保证经过验证的工艺由经过确认的人员来实施。

(2) For validated processes, the monitoring and controlmethods and data, the date performed, and, where appropriate, the individual(s)performing the process or the major equipment used shall be documented.

    2)对于验证的工艺而言,实施的日期、控制和监控的方法和数据以及相应的实施工艺的人员或主要使用的设备都应当予以记录。

(c) When changes or process deviations occur, themanufacturer shall review and evaluate the process and perform revalidationwhere appropriate. These activities shall be documented.

c)当出现变更或工艺偏差时,制造商应当审核和评估该工艺并适当的进行再确认。这些活动应当予以记录。

分享给身边的朋友
资讯推荐
CMDE:7个器审常遇问题解答

CMDE:7个器审常遇问题解答

中医诊所大爆发,办证只用一天

中医诊所大爆发,办证只用一天

四大热词总结2017中药行业重磅政策与企业大动作

四大热词总结2017中药行业重磅政策与企业大动作

设备捆绑耗材销售,医械企业被罚!上海工商出手了

设备捆绑耗材销售,医械企业被罚!上海工商出手了

北京卫计委发布采购14台大型医疗设备 价值上亿

北京卫计委发布采购14台大型医疗设备 价值上亿

资讯排行