GMP环境下清净室设施设备法规要求和国际趋势.pptx.ppt

CONCLUSION OUTLOOK * Abteilung: * Last but not least There is only GMP with a littlebit of variations Conclusion * * Abteilung: * GMP-PIC/S The question of whether the EU and PIC/S GMP Guides will remain equivalent depends basically on two factors: whether both parties are interested in keeping their GMP guides equivalent regarding requirements; and whether more EC legislation will be integrated in the EU GMP Guide, making it an EU specific guide rather than a universal guide. * Abteilung: * PIC Scheme Purpose of the Scheme to pursue and strengthen the co-operation established between the Participating Authorities in the field of inspection related to the manufacture of medicinal products and associated activities with a view to maintaining the mutual confidence and promoting quality assurance of inspections. to provide the framework for the sharing of information and experience on a voluntary basis. to co-ordinate mutual training for inspectors and for other technical experts in related fields. to continue common efforts towards the improvement and harmonization of technical standards and procedures regarding the inspection of the manufacture of medicinal products and the testing of medicinal products by official control laboratories. * Abteilung: * PIC Scheme to continue common efforts for the development, harmonization and maintenance of Good Manufacturing Practice (GMP), and to extend the co-operation to other competent authorities having the national arrange- ments necessary to apply equivalent standards and procedures with a view to contributing to global harmonization. Purpose of the Scheme * Abteilung: * PIC Scheme Short PIC’s overview PIC/S EMEA (Ad hoc GMP Inspectors Group) STANDARDS (CONSULTATION PROCEDURE) TRAINING European Commission STANDARDS (CONSULTATION PROCEDURE) TRAINING EU Heads Of Agencies EU Joint Audit Programme Sharing of resources