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| On sampling point selection of HVAC qualificaio discussion n and daily environmental monitoring in pharmaceutical clean room |
| Ren Xingzhu |
| The Fourth Construction Corporation Ltd., of China Electronics System Engineering , Shijiazhuang 050000, China |
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Abstract The selection principle of the number of sampling points for clean plant air-conditioning system confirmation and daily environmental monitoring has always been a topic of discussion in the pharmaceutical industry. In this paper, by comparing the domestic and foreign drug regulatory agencies to confirm and daily environmental monitoring different requirements, which for the confirmation process, the selection of sampling points is relatively clear, the owner can according to the product sales market, comprehensive consideration, in accordance with the most stringent standard selection. However, if there is no clear requirement for environmental monitoring sampling points, assessment and confirmation should be carried out based on the production process, product characteristics and environmental level, and reference suggestions are given in the document. The confirmation and daily environmental monitoring of clean plant and air conditioning system are two independent processes, reflecting the different state of the system respectively and avoiding mutual substitution.
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| 1 ] 国家食品药品监督管理局. 2011年第16号公告 中国GMP2010年版，附录1: 无菌药品[EB/OL] [2021-12-22].https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20110224164501312.html.
[ 2 ] Eudra Lex-Volume 4 - Good manufacturing practice (GMP) guid-
elines, Annex 1: Manufacture of sterile products（second targeted stakeholder’s consultation）[EB/OL]. (2020-02-22)[2021-12-22]. https://ec.europa.eu/health/sites/default/files/gmp/
2020_annexlps_sterile_medicinal_products_en.pdf.
[ 3 ] ISO 14644-1: 2015, Cleanrooms and associated controlled enviro-
nments — Part 1: Classification of air cleanliness by particle concentration [ S ].
[ 4 ] 国家药品监督管理局 2018年第85号公告 无菌工艺模拟试验指南（无菌制剂）[EB/OL] (2018-09-13)[2021-12-22]. https://www.cfdi.org.cn/resource/news/10795. html.
[ 5 ] GB/T 16292-2010,医药工业洁净室（区）悬浮粒子的测试方法[ S ]. |
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