ispe china annual conference 2012 april 16-17 2012 beijing 1 current situation and solutions of...

ISPE China Annual Conference 2012

April 16-17 2012 Beijing1

Current situation and solutions of Chinese GMP implementation

Wu Jun

2012.4.17


Main contentsPart 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

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Part one: History and achievements of Chinese GMP

implementation


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•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.


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

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Part two： Revision clue of 2010 issue GMP and the transform the

concept of drug monitoring

ISPE Chaina Annual Conference 2012 7

•compliance符合性

•effective有效性

•Transform the concept of drug monitoring


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

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GMP system 2010 ＝ product technology ＋management system

•Product technique

•Equipment cleaning•Environment monitoring

•Quality standard•Quality control

•Premises

•utilities

•equipment

•Internal supply chain•Production plan

•Management duty •person•education

•Quality assurance •Continuous improvement


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


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


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

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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

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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

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ISPE Chaina Annual Conference 2012

•Current situation of Chinese GMP implement ？

•Do in burst

•A period of time

•Just deal with



Part three: Bottleneck analysis during Chinese GMP implementation


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!


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


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

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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

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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

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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

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Bottleneck 5： lack of pharm. Engineering knowledge system

• Lack of the necessary research on basic theory

• Lack of complete system of pharm. Engineering education

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Part Four: Discussions on GMP implementing ways in the future


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

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Method 2：

• Build up the BbD application system• Product design• Technology design• Economical production system design

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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

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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


Thanks 谢谢 !

ispe china annual conference 2012 april 16-17 2012 beijing 1 current situation and solutions of...

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