Urs for Purified Water Systems - Free download as Word Doc (.doc / .docx), PDF File (.pdf), Text File (.txt) or read online for free. The document discusses considerations for a User Requirements Specification (URS) for a purified water system.

2013年4月9日 · A User Requirement Specification (URS) is issued by the user to define the system requirements. Issuing a URS serves many purposes. For example it: Specifies the system’s parameters, regulations, and standards; Establishes the base for pricing the new system; Establishes the base for design, manufacturing, and validation; Specifies deliveries

The importance of having a solid user requirements specification (URS) prior to engaging equipment vendors cannot be overstated. While validation processes are commonplace in the pharmaceutical industry, we have found that many managers responsible for the purchase of a new purified water system have difficulty writing a high-quality URS.

The objective of this URS is to define and document the requirements of the User Requirement Specification for pure water generator system for CIP purposes at SinaDarou Pharmaceutical site. These requirements will assure that water treatment systems will correctly and reliably perform its intended functionality.

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1.2.1 Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical products. It has unique chemical properties due to its polarity and hydrogen bonds. This means it is able to dissolve, absorb, adsorb or suspend many different compounds.

URS的全称是User Requirement Specification（用户需求说明）。 在 EU GMP Annex 15 中指出，设备、设施、公用设施或系统的要求应在URS和/或功能规范中定义。 在此阶段还需要建立质量的基本要素，并将所有GMP风险降低到可接受的水平。 所以，URS应该是整个验证生命周期中的参考点。 在中国GMP附录“确认与验证”中指出，URS是使用方对厂房、设施、设备或其他系统提出的要求及期望。 从上述的主流法规中我们可以看出，URS是用户对厂房、设施、设备或其他 …

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This document outlines requirements for a purified water distribution system for a pharmaceutical company. It specifies that the system must include a 20,000 L storage tank constructed of stainless steel, along with various filters and a distribution skid.

This document outlines the user requirements for a water for injection generation system. It includes sections specifying the operational requirements such as inputs/outputs, utilities needed, instrumentation, and process controls. It also covers GMP requirements including material specifications and cleaning validations.