Master of Pharmaceutical Engineer,(Tian Jin University),MBA (Hong Kong University),Bachelor (Xi’an-Jiaotong University),Senior,EngineerNational Specialist for the Pharmaceutical plant in bidding project.

2017～ Now  GM of Production Base of  Ascentage Pharma

2014～2017  General Manager of  Hangzhou Alicon Pharm SCI/TEC Co., Ltd.

2011～2014  General Manager of  Liaoning Sunshine Tech. Develop. Ltd.

Vice General Manager 0f Jiangsu Sunshine         Medical Technology Co.,Ltd.

2008～2011  President（Operation system） 0f Guilin Pharmaceutical Co.,Ltd. (Belong FOSUN Pharma Group)

2005～2008  Active Director of Engineering region

Project dept. Manager and Engineering dept. Manager of Xian-Janssen Pharmaceutical Ltd

1994～2005  Plant leader assistant, Project Manager of Xian-Janssen Pharmaceutical Ltd

Integrating requirement from all sides and carving out the blueprint for sterile production

Thought determines the way out.

Sterile product is closely related to human life and healthcare, and producing in scientific way is the core.

The concept that quality is based on design (QBD) is getting more important and the concept is also included in new version of cGMP, stressing its effective connection to drug registration and marketing strategy.

Design institute turns client’s(stakeholders’) idea into drawing, clients (stakeholder) is included but not limited to: Project Manager, Quality related staff, Scheduler for new product, Marketing staff, BD staff, Management Team, Investor, Governor.

Quality is under control and the product is safe and effective is the first principle for pharmaceutical research and development, and initial design of pharmaceutical will finally determine the quality concept.

The process from pharmaceutical research and development to bulk production is: research and development, small-batch production, medium-s production, bulk production. The outcome of pharmaceutical research and development is based on the result of engineering design (plant, workshop), thus design in QBD covers research and development design and engineering design. Design institute for pharmaceutical industry executes the design for plant engineering design and also ensure the delivery of research and development design.

The factors to design qualified plan is: client requirement, law and regulations, codes of practice, GMP factors(personnel, equipment, material, method, environment).

Personnel: people involving in production

Equipment: equipment used during production

Material: material used during production

Method: production method

Environment: environment during production

The core for GMP is to prevent mixed batch, contaminated product and cross- contaminated product.

To build up a new plant, production characteristic will be analyzed on the base of national regulation, GMP, and government plan for this area. A reasonable design plan will be offered after take about conditions into consideration.

5 factors(personnel, equipment, material, method, environment) will be collected. Combined with client requirement, a specific engineering design plan will be proposed that ensure product quality and safety.

Factors needed for Sterile plant design (Except for sterility guarantee measure)

Plant finance situation, plant plan, design difficulty, design concept, base of design, warehouse, partition layout, personnel flow, visitor path, layout for interlayer, layout for production workshop, office block, automation system, etc.

A well-planed blueprint design is the foundation to build a better future.