欧盟GMP附录1分析.ppt

Time for a new EU GMP “Sterile Products Annex” ? Or Sterile Products Processing Future Regulatory Compliance with what ??? Annex 1 Changes Proposal---- A significant review of Annex 1 of the EU GMP should be undertaken Because There have been many changes in practice and standards since Publication in 1997. Foundation in the 1983 UK Orange Guide GMP now showing its age. The Environmental requirements are the main areas requiring attention. Particle ClassificationBio-contamination ControlHEPA filter selectionFilter TestingRoom PressurisationAir exchange ratesUni-directional airflow system velocityPerformance Monitoring Harmonisation OR Proliferation Order to the confusion EU GMP Annex 1 content 1-6 General environmental requirements 7-9 Isolation technology 10 Blow-fill-seal technology 11 Terminally sterilised products 12 Aseptic preparation 13-21 Personnel 22-31 Premises 32-36 Equipment EU GMP Annex 1 content 37-39 Sanitation 40-54 Processing [note: clause 42 revised July 2001 to modify “Process simulation media fill” objectives and requirements] 55-61 Sterilisation 66-68 Moist heat 69 Dry heat 70-75 Irradiation EU GMP Annex 1 content 76-81 Ethylene oxide 82-87 Filtration of medicinal products 88-90 Finishing of sterile products 91-93 Quality control New Standards “Cleanroom” “Air Filtration” The Standards are Generic - not application specific The status of the Standards being prepared by ISO TC 209 Classification by airborne 14644-1 Published Monitoring for Compliance 14644-2 Published Measurement Testing 14644-3 CD-DIS Design, Construction, Start-up 14644-4 Published Cleanroom Operations 14644-5 DIS-FDIS Separative Devices 14644-7 DIS-FDIS Bio-contamination Control 14698-1,2 3 2nd DIS Terms and definitions 14644-6 CD Molecular Contamination 14644-8 WD Status of US Fed Std 209ENovember 2001 Status of US Fed Std 209ENovember 2001 EN ISO 14644-12 have been published, IEST have recommended to the US GSA that maintenance of US Fed Std 209 be suspe