ECA CCS指南-附件1：差距评估实例（非详尽无遗）.docx

Attachment 1: Example of a gap assessment (non-exhaustive) 附件1：差距评估实例（非详尽无遗） Key Areas Key Elements Detailed CCS Elements Annex 1 rev12 draft reference Identified potential gaps (or documentation improvement need) versus Annex 1 draft expectations Key supporting Site Strategies, Rationales, Risk assessments Include Reference, title and if possible hyperlink to the Key Site Procedures Include Reference, title and hyperlink to the document Facilities, equipment, Utilities and Infrastructure Design, Qualification, Maintenance and Control Facilities Facilities Design Facility design requirements (plant layout, air filtration, material of construction, cleanability, airlock design, logical and chronological activities flows ) 4.1, 4.2, 4.3, 4.5, 4.6, 4.7, 4.8, 4.9 4.10, 4.11, 4.12, 4.13, 4.17 6.6 6.21 4.1 explain how controls and monitoring are scientifically justified and capable of evaluating the state of environmental conditions for cleanrooms, airlocks and pass-throughs used for material and equipment transfer 4.3 Barriers should be considered in the CCS. Any alternative approaches to the use of RABS and Isolators should be justified Develop the current material transfer and airlocks sections using wording of 4.10, 4.11, 4.12, 4.13 To be filled out accordingly To be filled out accordingly HVAC system design requirements (Air Filtration/HEPA Filters, Pressure cascades, Temperature, RH, locations of air inlets outlets, ducts cleanability, air exchanges rates, alarms settings and controls ..) 4.13, 4.14, 4.15, 4.16 4.35 Develop an adequate section to cover 4.16 Setpoints and the criticality of pressure differentials should be documented within the CCS / where alarm delays are set, these should be assessed and justified within the CCS To be filled out accordingly To be filled out accordingly Area Classification / Grade cascading 4.1, 4.4, 4.12, 4.13, 4.20 8.14 No gap identified Physical segregation of activities (dedicated facility/area, use of closed systems, o