奥星制药用水系统技术经理张功臣
Philip Zhang
Pharmaceutical Water System Engineering Technical Manager
Philip Zhang, Long term experience in pharmaceutical engineering design. Work as technical manager for water system engineering (CIP/SIP, Purified Water, Water for Injection and Pure Steam System), Take charge of project design, project execution arrangement and supervision. Profound knowledge on pharmaceutical engineering regulations (Chinese, European and FDA GMP) and guidelines of 3A, ISPE and ASME BPE on pharmaceutical clean room and clean utility system. Member of ISPE and certified training by ISPE, Singapore in April, 2008.
Abstract of speech
In this article, the feature of pharmaceutical water and relevant fundamental theory were introduced. The method consistent with the updated 2010 GMP & pharmacopoeia requirements was presented. After the quality control design key point was introduced, the design requirements and methods for supervision and control system and for the main composition of pharmaceutical used water system were proposed. Finally, the sanitation, sterilization and deviation rectify of pharmaceutical water system was introduced.
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