Industry news
Necessity of the preparation of URS for pharmaceutical water purification equipm
Time：2017-04-16 11:55:54
（1）Enterprise water consumption, water standards
（2）Process requirements for water purification equipment, water injection equipment
（3）The main parts of the brand, model
（4）Risk control requirements
（5）Automatic control requirements
（6）Acceptance criteria
（8）Installation requirements, etc.
Water purification equipment, water for injection preparation of URS is the first step to getting successful validation key with URS, we have further validation activities, no verification of URS target is not clear. The 2010 edition of the GMP drafting group core group members, vice president, Chinese medical equipment Engineering Association of Sichuan Province medical insurance of President of product quality management association Zhong Guangde pointed out that the 2010 version of GMP that enterprises should design according to their own personalized product innovation system, and numerous experiences of developed countries in the pharmaceutical industry has also proved that an effective operation of the quality management system from some basic elements of the system, and these elements formed must be based on scientific and complete URS. URS reflects the QbD - quality from the design, the new version of URS GMP preparation reflects the front-end design concept of drug production, the design, procurement and verification plays an important role in three aspects. Enterprises must attach great importance to the preparation of URS, URS is the user to the equipment / system specific output requirements of the detailed description of the equipment / system design basis, determines the performance of the equipment / system. The URS is the source of the validation activities, but also the final basis for the performance of the confirmation。
Shenzhen City Huitong Source Environmental Protection Technology Co., Ltd. in the pharmaceutical with purified water equipment and water for injection system has in-depth experience in the engineering construction, hope more and industry professionals to discuss and exchange。
