1. ISPE China Annual Conference 2012 April 16-17 2012 Beijing 1 Current situation and solutions of Chinese GMP implementation Wu Jun 2012.4.17

2. ISPE China Annual Conference 2012 Main contents Part one: History and achievements of Chinese GMP implementation Part two: Revision clue of 2010 issue GMP and the transform the concept of drug monitoring Part three: Bottleneck analysis during Chinese GMP implementation Part four: Discussion of GMP implementing ways in the future 2

3. ISPE China Annual Conference 2012 April 16-17 2012 Beijing 3 Part one: History and achievements of Chinese GMP implementation

4. ISPE China Annual Conference 2012 4 4 1998 1992 1988 1984 1982 The fist GMP was issued by Chinese Pharmaceutical Industry Administration. The State Pharmaceutical Administration issued a GMP first established by the government. Ministry of Health issued the first legal GMP Ministry of Health revised the GMP SFDA revised the GMP again Chinese GMP history 2011 SFDA revised the GMP again.

5. ISPE China Annual Conference 2012 30 years achievements in China GMP pursue Built up the concept of drug production management concept. Promoted the modernize process of Chinese pharm. industry Established the complete compulsory certification system 5

6. ISPE China Annual Conference 2012 April 16-17 2012 Beijing 6 Part two ： Revision clue of 2010 issue GMP and the transform the concept of drug monitoring

7. ISPE Chaina Annual Conference 2012 7 compliance 符合性 effective 有效性 Transform the concept of drug monitoring

8. ISPE China Annual Conference 2012 The main purpose of GMP revision Transforming the concept of drug Monitoring Promoting the technical level of Chinese pharm. Industry Pushing on the self-development of the Pharm. company 8

9. ISPE China Annual Conference 2012 GMP system 2010 ＝ product technology ＋ management system Product technique Equipment cleaning Environment monitoring Quality standard Quality control Premises utilities equipment Internal supply chainProduction plan Management dutyperson education Quality assurance Continuous improvement

10. ISPE China Annual Conference 2012 The essence of GMP management Reduce the process lose pollution Optimize the resources arrangement to cut the product cost Improve the production efficiency Continuously improve to cut the process control cost

11. ISPE China Annual Conference 2012 Problems of drug monitoring at present hardware ： related to rebuild the premise and workshop software ： reverse the original documentation system, focus on risk management slogan ： we are in compliance with the GMP ！ But indeed, only in compliance with the certification monitoring 11

12. ISPE China Annual Conference 2012 Problem 1:product technique and quality control lack of systematic product technique research Have not yet built up the systematic product transfer system Lack of research and control of product pollution mechanism and cleaning method Further improvement is necessary on setting the scientific and systemic product quality standard and detection method 12

13. ISPE China Annual Conference 2012 Problem 2: hardware construction myopia 、 material thought predominate, lack of systemic and strategy hardware construction Pharm. Engineering design lack of integration ability of the technology, architecture, utilities and production operation Technology equipment lack of the understand of the pharm. Production technology requirements Lack of Validation methods of the technology equipment and utilities 13

14. ISPE China Annual Conference 2012 Problem 3: The infrastructure of the enterprise management Modern pharm. Operation system has not built Advanced management method is difficult to implement Misunderstand the role of the quality management Has not built up the technology support system 14

15. ISPE Chaina Annual Conference 2012 Current situation of Chinese GMP implement ？ Do in burst A period of time Just deal with

16. ISPE China Annual Conference 2012 April 16-17 2012 Beijing 16 Part three: Bottleneck analysis during Chinese GMP implementation

17. ISPE China Annual Conference 2012 GMP implementation and benefits Preventive quality management increase the profits First time right create the profits Quality reputation decide the profits Resources optimization bring the profits Continuous improvement deliver the profits establish the good culture atmosphere!

18. ISPE China Annual Conference 2012 GMP implementation difficults dogmatism ？ –Management is far from the reality ； –Implementation is far from the reality 。 formalism ？ –In technical work –In quality control opportunism ？ –Myopia pragmatism –Pursue the trend

19. ISPE China Annual Conference 2012 Bottleneck 1 ： out environment need to improvement Invite bids in low price lead to malicious competition Partly Law and regulations need to be perfected Social integrity is not high 19

20. ISPE China Annual Conference 2012 bottleneck 2 ： pharm. Technology and operation system can not operate effectively Product technology and technical transfer system is not perfect Drug production management system is not perfect Professional technical management system is not perfect 20

21. ISPE China Annual Conference 2012 Bottleneck 3 ： lack of talents team Professional idea is rigid Knowledge structure of professional is not reasonable The quantity of professional is not enough The development of the professional is limite 21

22. ISPE China Annual Conference 2012 Bottleneck 4 ： basic manufacture technology level need to be improved The production of Auxiliary and package material is lag The drug equipment is lag Engineering design, installation and project management is lag 22

23. ISPE China Annual Conference 2012 Bottleneck 5 ： lack of pharm. Engineering knowledge system Lack of the necessary research on basic theory Lack of complete system of pharm. Engineering education 23

24. ISPE China Annual Conference 2012 April 16-17 2012 Beijing 24 Part Four: Discussions on GMP implementing ways in the future

25. ISPE China Annual Conference 2012 Method 1 ： Build up the systemic and scientific concept of laws and regulation, quality and competence Offer the corresponding outer environment of the drug register and monitoring requirement ； Build up the strategy GMP implementation method by scientific and systemic think Establish the continuous improvement GMP system which can build up the company core competence 25

26. ISPE China Annual Conference 2012 Method 2 ： Build up the BbD application system Product design Technology design Economical production system design 26

27. ISPE China Annual Conference 2012 Method 3 ： Strengthen the knowledge system building and talents development of the pharm. Engineering Establish the Chinese pharm. Engineering system Basic theory research on the key technologies during the pharm. Engineering implementation Perfect and advanced College pharm. Engineering education system Reinforce the continue education on conscious, knowledge and competence of the current professional 27

28. ISPE Chaina Annual Conference 2012 Current situation of New GMP execution Neglecting the basic technical construction, focusing on the renew of documents Neglecting the understand GMP articles, focusing on the understand detail words Neglecting the complement and improvement of drug manufacturing system, focusing on the article compliance requirement Neglecting the final control goal of GMP, focusing on formalize compliance articles when you go too faraway, don’t forget where you want to go

29. ISPE China Annual Conference 2012 29 Thanks 谢谢 !