GMP清净室的模组化设计、施工与启动 (part 2).pptVIP

Life Sciences Contamination Forum, Medicinal Products 2001/83/EC – manipulated cells Amendent 2003/63/EC Part IV, Annex I Advanced Therapy Medicinal Products – gene therapy, cells, tissues GMP Directive 2003/94/EC Regulation (EC) No 1394/2007 on advanced therapy medicinal products Valid from 30 December 2008 Guidelines in line with the principals of GMP (Chapter 2 Article 5) EMEA/CHMP/4108697/2006 guideline - from Sep 1, 2008 Tissues and cells 2004/23/EC – unmanipulated cells Amendments 2006/17/EC, 2006/86/EC to be a ”GMP like” system: Tissue establishments Quality Management System incl personnel, equipment, materials, reception, storage, labelling, distribution, quality review Facilities/premises - Tissues and Cells exposed to the environment should be carried out in GMP Grade A environment surrounded by GMP Grade D background GMP - Good Manufacturing Practice GLP - Good Laboratory Practice Dedicated laboratory with restricted access, ante room, gowning, etc Processing in a controlled environment Screening of donors Microbial screening of processed products Cryo storage in nitrogen vapour Applies to Tissues and Cells which are exposed to the environment during processing, without a subsequent microbial inactivation process Air Quality as measured by Particle Counts and Microbial Colony counts equivalent to those of Grade A as defined in the current European Guide to Good Manufacturing Practice (GMP), Annex 1 and Directive 2003/94/EC Background Cleanroom environment appropriate for the processing of the Tissues / Cells but at least equivalent to GMP Grade D in terms of particles and microbial counts Annex 1 EMEA Aseptic Processing guidelines Cleanroom monitored for Environmental conditions, Airborne Particle contamination and Microbiological contamination Over pressure cascade differentials, 12.5 Pa each Environmental Monitoring Programme At Rest and In Operation Processing in “closed” system OR within Class II MBSC – Grade A Annex 1 GMP All cr