ISPE Good Practice Guide Critical Utilities GMP Compliance

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上一期我们分享了第一章节，今天继续第二章节部分内容。

2.1.4    Public Water Compliance 公共用水合规性

When a public drinking water sourceisused, the responsibility for complying with thedrinkingwaterregulations of the region usually falls tothe drinking water provider. However, it remains theuser’s responsibility toensurethat compliance of all drinkingwater attributes has beenachieved for water used at the pharmaceuticalfacility; this responsibility includes year-round verificationas there may be seasonal variability inwater supply quality.

当使用公共饮用水水源时，遵守本地区饮用水法规的责任通常由饮用水供应商承担。但是，用户仍有责任确保制药工厂使用的水符合所有饮用水的质量属性;这种责任包括全年的确认，因为供水质量可能存在季节性变化。

2.1.4.1               Public Water Provider Certificationand Verification 公用用水供应商认证和确认

ICH Q7 [5] requires identity testing on manufacturingmaterials in most cases:ICHQ7 [5]要求对大部分生产物料做鉴别检查：

“At least one test to verify the identity of eachbatch of materialshould beconducted….A supplier’sCertificate of Analysis can beused in place of performing other tests, provided that the manufacturer hasa system inplace toevaluate suppliers.”

至少要进行一项测试来确证每批物料的类别。只要生产者有适当的供应商评估系统，供应商的分析报告可用来代替其他的测试。

Accordingto theGMPs, a certificateof complianceforany raw material should neverbe accepted without verification ofauthenticity and accuracy. That verification may involve an audit of thefacility toviewoperations and the raw dataassociated with the certification, with organizations checkingsome attributes withtheir owntesting. Theserules apply to any public drinking water providerincludinglocal, regional, or other drinking water authority. If thelocalwater provider refuses to allowa sitevisit/audit, then the levelof risk is potentially increasedand the level of monitoring by the organization shouldincrease tocompensate.

根据 GMPs 的规定，任何原辅料的合格证明在未经确认真实性和准确性的情况下不应被接受。该确认可能涉及对工厂的审计，以查看及证明相关的操作和原始数据，企业需通过自己的测试核查一些相关属性。规定适用于任何公共饮用水供应商，包括地方、地区或其他饮用水主管部门。如果当地水的供应商拒绝接受现场检查或审计，那么风险水平就可能增加，而该企业也应提高监测水平作为补充。

Also, drinking water compliance applies primarily to thewater at the source, prior to enteringthe delivery piping network. Water maytravel great distances during an extendedperiod throughpiping of unknown integrity resulting inreducedquality at the destination.

此外，饮用水的合规性从根本上也适用于在进入分配管路系统之前的源水。水在很长一段时间内通过完整性未知的管道并运输较长的距离，从而导致使用点的水质下降。

It is the user’s responsibility to verify that any provided certification of compliance withdrinking water regulations is accurate. Therefore, it may beappropriateforthe pharmaceutical facility to periodically verify the drinking water’s compliance. This includes samplingthedrinking water at themanufacturer’s sitein one or more locations toverify that quality criteriaare being met. Thenumber

of locations andfrequency of samplingshould be determined based on a risk assessment.

用户有责任核实任何提供的饮用水合规性证明文件的准确性。因此，制药企业应定期核查饮用水的合规性。包括在生产现场的一个或多个饮用水使用点进行取样检测，以证明水质能达到质量标准。取样点的数量和取样频率应基于风险评估结果来决定。

Not all quality attributes in aset of drinkingwater regulations arerequired tobe tested annually norwith every sample, particularly wherea history of compliance has been demonstrated bythe manufacturingfirm through analysis of theincoming supply water. Theselection ofparameters fortesting shouldbe based on a combination of risk assessment and thedrinking water regulationsapplied tothe manufacturing site. It may beappropriate during a drinking water complianceaudit of a water authority’s facility and its testing datato observe consecutiveyears of historical testing datain order toconfirm that all attributes have beentested at least at therequiredfrequency.

一组饮用水法规中所有质量属性并不是都要求每年都进行测试，也不是每个样本都进行全项检验，特别是在生产商通过分析证明供水的质量有历史符合性证明的情况下。测试参数的选择应该基于风险评估并结合适用于生产现场的饮用水法规要求。在对水务管理局的设施及其测试数据进行饮用水合规性审计时，观察连续几年的历史检测数据，以确定饮用水所有的属性至少都按规定的频率进行了测试。

2.1.4.2                 Absence of Reliable Certificationor Useof a PrivateWater Source

缺乏可靠的证明或使用了私人水源

There arescenarios where a pharmaceutical facility may have its own private water sourceforuse in manufacturing andfurther purification. Theremayalso be instances where thedocumentation supportinga drinkingwater provider’s certificationof compliance is absent, incomplete, untrustworthy, or not one of the acceptablestandards. In thesescenarios, the pharmaceutical facility is responsiblefordemonstrating compliance toan acceptable set of drinking water regulations.

有些情况下，制药公司可能有自己私有的水源用于生产和进一步纯化。也可能饮用水供应商的合格证明文件缺失、合规性证明缺失、不完整、不可信或没有一个可接受的标准。在这种情况下，制药企业需负责提供符合一组饮用水法规的证据。

The potential for variability, or when variability has been demonstrated, in drinking water quality inthese situations is a factor in howoften testingshouldbe performed. Minimally, duringthe first yearof source testing, the robustness of the supplied water and anytreatment needed tobring thesource water into complianceshouldbe performed multiple times(e.g., quarterly or monthly,depending on therisk assessment of the water supply) until suchtime as the quality variability isdiscerned. Thereafter, an appropriatesampling frequency depends on a further risk analysis. Forexample, ina situation with a high-risk water supply, the first year may include weekly water sampling. If all dataisacceptable, in thesecondyearsampling frequency may be reduced tomonthly, and if results are good,may be reducedtoquarterly in thethird year. However, ina jurisdictionwhere a manufacturer has existingoperations fedfrom the same water supply withconsistently good quality,reduced sampling frequency may occur muchmorerapidly.

当水质可能发生变化或者已经出现的变化的情况下，饮用水应多长时间检测一次就是一个问题。至少，在水源测试的第一年，应多次（例如，季度或每月，取决于供水的风险评估）对供水的稳定性和使水源符合要求所需的任何处理进行多次测试，直到发现水质变化。此后，合适的取样频率取决于进一步的风险分析。例如，在高风险供水的情况下，第一年可能需要包括每周取水样。如果所有数据都是可以接受的，可以在第二年的取样频率减少到每月取样，如果结果良好，可以在第三年的抽样频率减少到每季度取样。然而，在某一区域内，生产者使用相同的供应商，水质良好并始终如一，降低取样频率的速度可能会更快。

2.1.4.3                 Source Water Pretreatment and SamplingLocation 源水预处理及取样点位置

It may benecessary to treat the water in order tocomply withthe drinking water standards. Thenature of that treatment depends on thenature of the noncompliance inthe source water. Ideally, compliance withthe selected drinking water regulations shouldbe shown with thewater enteringthe purificationsystem. However, it is generally acceptably compliant toobtain samples takenfrom as far into thewater system as the furthest Point of Use (POU); however, samplingmaybe required at other locations that are deemed high risk dueto infrequent usage, or due tothe nature of theuse of the water dispensed. It is noteworthy that in large facilities there may bebranches (not recirculating) of potablewater that see infrequent use andcouldbe prone to microbial contaminationifnot regularly flushed. If thereare secondary storage tanks for potable water withtheir own distribution networks, this risk thenincreases, and sampling from thePOUof these systems should bedone.

为了符合饮用水标准，有必要对源水进行处理。处理的性质取决于源水性质哪方面不合规。理论上说，进入纯化系统的水应符合所选的饮用水法规。但是，如果从水系统最远的使用点(POU)取得的样品符合规定，一般是可以接受的;在其他不经常使用而被认为是高风险的用水点或因为水分配使用的性质要求进行取样。值得注意的是，在大型公司可能存在不常使用的饮用水分支(非循环)，如果不定期冲洗，可能容易受到微生物污染。如果有饮用水的二级储罐和它们自己的分配网络，这种风险就会增加，并且应从这些系统的最远使用点进行取样。

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CiKeXinTiao

楼主快更啊，周末加班儿来看更新

验证资料收集

CiKeXinTiao 发表于 2020-12-6 10:07
楼主快更啊，周末加班儿来看更新

哈哈一直挺忙的，没时间弄这些，尽量多更一点