URS is the product specification established by pharmaceutical companies according to their own production requirements. URS is also a platform for fair selection of purified water equipment suppliersPurified water equipment and injection water equipment URS generally includes the following aspects1. Enterprise's own water consumption and water use standard2. Purification of water equipment and process requirements for water injection equipment3. Brand and model of main accessories4. Risk control requirements5. Automatic control requirements6. Acceptance standards7. Installation requirements, etcPurified water equipment, water for injection to write the first step in the URS is a key to successful validation, with URS is we further validation activities, no URS verification goals is not clear.
The 2010 version of GMP drafting team core group members, vice President of China medical equipment engineering association, sichuan medical guarantee the product quality management association Zhong Guangde pointed out that the 2010 version of the GMP stressed that the enterprise should be prepared at the design their own personalized product innovation, and the pharmaceutical industry in the developed countries experience countless also proved that an effective operation of quality management system from the basic factors of the system,Meanwhile, the formation of these elements must be based on the well-developed URS.URS reflects QbD -- quality originated from design. The URS of the new GMP reflect the front-end design concept of drug production, which plays an important role in design, procurement and verification.URS, a detailed description of the specific output requirements of the equipment/system by users, is the basis for the design of the equipment/system and determines the performance of the equipment/system.URS is the source of verification activities and the final basis for performance verification.