1-公用系统(空调、压缩空气、纯化水)的检测标准及频率主要系统的用途,注意区分生产和QC实验室,具体检测标准主要看法规及各种药典要求,比如生产用的空调系统的检测标准参考【GMP 附录1:无菌药品】,而对于QC实验室的空调系统的检测及周期参考【中国药典】2020年版【9205 药品洁净实验室微生物监测和控制指导原则】。
2-检测周期需要区分验证及日常监测,参考 ISPE GPG:Sampling for Pharmaceutical Water,Steam,and Process gases 对于检测周期的描述:应根据所生产的产品,启动风险评估,确认取样点、取样频率及检测项目,且需要制定警戒限度和纠偏限度。这份指南内容非常全面,建议研读参考。
1.1.4 How often do we need to sample?
Sampling frequency depends on the system and the grade of the critical utility. In the case of Water For Injection
(WFI) grade water, it is an expectation that water samples will be taken from each Point Of Use (POU) and sample
location in the distribution system at least once per week during validation. Industry has continued to utilize this
same sampling frequency beyond the completion of the Performance Qualification, although it is not mandated. By
contrast, purified water has no such preconceived sampling requirements, so the end user is not mandated to follow
any specific schedule during or following validation, although many companies also having WFI systems default
to the same frequency used on WFI systems. Pharmaceutical steam, compressed air, and process gases have
different frequencies during validation and ongoing operation. When no sampling frequency is specified, a risk-based
approach may be utilized in conjunction with the purpose of sampling to establish initial sampling frequencies. As
data is generated and an operating baseline is established, the collected data should be reviewed to determine if the
operating limits, Alert and Action Levels, and/or the sampling frequency may be adjusted (increased or decreased)
based on data generated on system operation and as established within operational SOPs.
中国GMP 2010 第九十六条 制药用水应当适合其用途,并符合《中华人民共和国药典》的质量标准及相关要求。制药用水至少应当采用饮用水。标准课件《中国药典2020》,从本行前面的超链接找到主题词,可见《中国药典》的具体章节。
USP online和EP 搜“purified water”和“water for injection”也有相应的章节和标准。
压缩空气参见识林主题词“压缩空气”,各种标准列的比较齐全,还有案例。链接为:http://lib.shilinx.com/wiki/index.php?title=%E5%88%86%E7%B1%BB:%E5%8E%8B%E7%BC%A9%E7%A9%BA%E6%B0%94
一些指导也可参见:ISPE GPG:Sampling for Pharmaceutical Water,Steam,and Process gases-2016
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