设备确认操作规程(英文).docVIP

PURPOSE: To provide a formal methodology to be followed during qualification of equipment. SCOPE: Applicable to qualification of new equipment, re-qualification of equipment, which has undergone major modification, relocation of equipment and Periodic Qualification as per schedule in Pharma manufacturing department. RESPONSIBILITY: Production, Engineering, Safety, Quality Control and Quality Assurance staff. DEFINITION: Qualification: Documented verification that the environment and equipment are appropriate for the designated function. User Requirement Specification (URS): A Requirement specification that describes what the equipment or system is suppose to do, thus containing at least set of criteria or conditions that have to be met. Functional Design Specification (FDS): Functional design specification is a document that specifies in a complete, precise, variable manner, the requirement design, behaviour or other characteristics of a system or component and often the procedures for determining whether these provisions have been satisfied. Specification that is offered by manufacturing based on URS and are agreed mutually. Design Qualification (DQ): Formal and systematic verification that the requirements defined in the specification phase are completely covered by the succeeding specification or implementation phase. Factory Acceptance Test (FAT): Testing conducted at the suppliers factory to determine whether or not a system specifies it’s acceptance criteria and to enable the user to determine whether or not to accept the system. PREPARED BY APPROVED BY AUTHORISED BY Department Head Unit Quality Assurance Unit Head Date : Date : Date : (CQA-56/F3/4) Installation Qualification (IQ): Documented verification that a system is installed according to written and pre-approved specifications. Site Acceptance Test (SAT): An acceptance test at the users site, usually involve the supplier.