确认，再确认和监测
送母亲什么花1. General The termsqualification, requalification and monitoring are often mixed up, especially ifthe somewhat different language from ISO standards is ud in读书计划怎么写
the GMP environment. Therefore, the three terms will be explained in the following andthen differentiated one from the other by way of the examples watersystem andclean room.
确认、再确认和监测经常混淆，特别是当那些语言略有出入的ISO标准用在GMP环境的时候。所以，接下来将对这三个术语进行解释，并通过列举水系统和洁净室的实例的方式对他们进行区分。Generaldefinitions according to GMP:
根据GMP他们的的定义如下:
墨鱼鸡汤∙Qualification: ensuring in the ca of new equipment/facilities or equipment entering into
rvice that they rve their intended purpo
确认：确保新的设备/设施或者经过维修的设备符合预期的使用目标
生活水泵房
∙Requalification*: ensuring that the equipment is still in the qualified state after a change AND periodical asssment of eqipment within defined time intervals 再确认：在设备变更或者定期评估后确保设备仍然在确认状态
Monitoring: supervision of equipment or a system - this can be performed continuously or discontinuously
寒冬图片监测：设备或者系统的监督性活动——可以间断或不间断实施。
汽车四轮定位
画平面图But the topic ofrequalification* needs to be considered in more detail. Strictly speaking,requalification is not mentioned in Annex 15 of the EU Guidelines to GoodManufacturing Practice which is the guidance document for qualification inEurope. But revalidation is described (e.g. article 45) and since qualificationis considered to be a subt of validation, a requalification also is required.Thereis no tting of time standards. But it should be stipulated when aperiodically recurring requalification has to be carried out. Therequirements should not be taken and met on a general basis but system-relatedand risk-bad. In many cas this is every 3 to 5 years. But in theca of a fully automated system for the visual inspection of parenterals forexample, it could be scheduled already every 1 to 2 years. It is very importantthat this requalification is not understood as a repetition of qual
ification.Usually, no new tests or measurements are necessary insofar asthe equipment concerned was not changed. Here, requalification is rather areview of data from routine operation.
Hence, thequality-related equipment or specification parameters are to be consideredand analyd as well as the changes in the equipment and the deviations thattook place in the period considered. An analysis of the logbook should also bepart of this evaluation. The document should end with a conclusion that informsabout the equipment's state: equipment still is considered to bequalified: Yes / No. By the way, GMP inspectors don't consider the annualproduct review (APR) as substitute for the requalification.
但是再确认的话题则需要更详细的考虑。严格的说，再确认不是欧盟GMP附录15要求的。但是再验证则是要求的，并且由于确认被认为是验证的子集，再确认也是需要的。它并没有时间标准的规定。但是应当规定何时周期重复进行再确认。这些要求不应当只满足于通用的标准，而应该基于风险和系统相关分析。在多数情况下，3~5年。但是注射类药物的全自动目视检查系统则需要1-2年。需要明确的是，这里的再确认并不是确认的重复活动。通常，关注的设备未发生变更是不需要新的测试的。这里，再确认更是一个日常运行数据的回顾。因此，将考虑和分析质量相关的设备或者规格参数，特别是设备的变更和考察期间发生的偏差。日志的分析也应当被包括在这份评价中。这个文件应当以设备的状态：设备仍在已确认状态：是/否的通告为结论收尾。另外，GMP 检查员不认为产品年度回顾可
以代替再确认。
2. Example pharmaceutical water
掇拾
例如水系统The firstvariation already aris in the ca of a water system. In the cour of the(first) qualification the terms qualification and validation become blurred. Usually,so-called dry runs are carried out during the performance qualification (PQ).This means that the equipment is operated with a substitute materialinstead of the product. Often the substitute material is water. The realproduct has to be ud in the subquent validation at the latest. In a watersystem, the product manufactured naturally is water. Therefore, the PQ, atleast the later part, also is considered to be a validation. In this ca, thequalification in three steps described by the FDA already many years ago, isindustry standard. But the single phas differ as concerns the frequency ofsampling and the number of sampling points. The complete qualification lasts upto one year in order to prove that asonal fluctuations of the feed water'squality as well as different operating conditions don't influence the qualityof the produced water.
在水系统（首次）确认过程中，术语“确认”和“验证”变得模糊不清。通常，在性能确认期间开展所谓的“空运行”。这意味着设备使用替代物料代替产品运行。通常替代物料是水。至少需要在随后的验证中使用实际产品。在水系统，生产的产品自然是水。所以，它的PQ，至少在后
期阶段，也应该被认为是一个验证。在这种情况下，FDA很多年前描述的三个步骤的确认就是行业标准了。但单个阶段关于采样频率和采样点的数量存在差异。为了证实原水质量和运行条件的季节性波动不影响所产水的质量，完整的确认需要持续一年A requalificationhas to be carried out after changes have taken place at the water systeminsofar as the change can influence the qualified state of the water system.The risk analysis carried out in the context of qualification shoulddemonstrate if this is the ca. This decision making process should be carriedout by means of the change control system in order to be able to understandalso at a later date why for example no qualification tests were necessary orwhy which requalification tests had been determined.
水系统发生变更后，如果该变更可能会影响该水系统的确认状态的，应该进行再确认。在确认背景下进行的风险分析应该证实这一点。为了在日后便于理解为什么可以没有确认测试的或者为什么采取那种再确认
测试，这个决策流程必须通过使用变更控制体系来进行。
As a general rule, requalification then consists of thetests that have demonstrated already during the first qualification for therelevant part of the equipment that the equipment was operatingcorrectly. Should there be a risk for the whole systemthe qualification has to be repeated. Then quality assurance has to decidewhether all phas really have to be carried out. The
