1、 2/62 FDA EU GMP 15 EMA GMP 3/62 FDA 4/62 FDA 2014 02 5/62 1 2 3 4 5 6 DMF 7 8 9 FDA 10 6/62 NDA BLA DMF IND 7/62 / / / 8/62 DMF DMF 9/62 10/62 11/62 EU GMP 15 12/62 EU GMP 15 2001 07 EU GMP 15 2014 02 06 13/62 15 11 ICH Q8 ICH Q9 ICH Q10 ICH Q11 QWP http:/ec.europa.eu/health/documents/eudralex/vol-
2、4/index_en.htm 14/62 - New Old Principle Principle General Organising and Planning for Qualification and Validation 7 Planning for validation 5 Documentation including VMP 9 Documentation 3 Qualification stages for equipment, facilities and utilities 14 Qualification 10 Qualification of established
3、(in-use) facilities, systems and equipment ( ) , (1 ) Process Validation 29 Process Validation 16 Verification of Transportation 4 0 Validation of Packaging 2 0 Qualification of Utilities 3 0 Validation of Test methods 3 0 Cleaning validation 13 Cleaning validation 7 Re-qualification 3 Change Contro
4、l 1 Change Control 7 Revalidation 2 Glossary 25 Glossary 15 15/62 15 15 16/62 - 2001 15 EU-GMP 11 17/62 - 15 2001 GMP 18/62 - 19/62 - 20/62 - / 21/62 - URS / FAT/SAT GEP 22/62 - 15 15 23/62 - 24/62 - (verification) (Validation) 25/62 - 26/62 - 3 27/62 - 28/62 - 15 29/62 - 30/62 EMA 31/62 2010 5 2012
5、 3 ( ) 2014 2 27 2014 8 32/62 EMA Guideline on process validation for finished products information and data to be provided in regulatory submissions 33/62 EMA FDA EMA FDA : :GMP : : PAT EMA FDA 34/62 EMA ( ) / 35/62 EMA 36/62 EMA ICH Q11 范围内 人用药 兽用药 无菌与非 无菌产 品 生物与生 物技术 药 品 疫苗 放射药品 组合 产品 的药 物 成 分 范围
6、外 医疗器械 膳食补充 剂 加药饲料 人体组织 FDA 37/62 EMA EMA 38/62 EUGMP&EMA EUGMP EMA FDA FDA FDA EUGMP&EMA ICHQ8R2/EMEA/CV MP/315/98 39/62 EMA 4. 1. 3. 2. 40/62 GMP 41/62 2010 2 2014 102 2014 06 17 2010 2 2013 3 21 2014 7 16 http:/ 010-88330812 42/62 CFDA GMP EU GMP 15 Principle General 3 7 5 9 8 14 16 Process Vali
7、dation 29 4 Verification of Transportation 4 Validation of Packaging 2 Qualification of Utilities 3 Validation of Test methods 3 12 Cleaning validation 13 4 Re-qualification 3 Change Control 7 12 25 43/62 1 2 3 4 44/62 - 45/62 - 46/62 - CQA&CPP GMP / 47/62 - 48/62 - 1. 2. 3. 4. 5. 6. 7. / 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 49/62 - 50/62 - 51/62 - 52/62 - CQA CQA : CPP CPP : 53/62 - 54/62 - CPV CAPA 55/62 - 56/62 - 1
