Chinese Pharmaceutical GMP Regulations Industry product price, Size, profit, capacity, production, Industry growth rate etc.

Latest Guide to Chinese Pharmaceutical GMP Regulations provides a comprehensive and thorough knowledge of the Chinese pharmaceutical GMP regulations to guide overseas pharmaceutical companies and multinational pharmaceutical companies to achieve a successful entry into the Chinese lucrative drug market and help overseas pharmaceutical companies and multinational pharmaceutical companies to make decisions on entry into the Chinese lucrative drug market.

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Summary

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate over 20 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.

Table Of Content 

Chapter 1 Introduction.. 5

Chapter 2 An Overview of Good Manufacturing Practice (GMP) for Drugs..11

2.1. General..11

2.2. Glossary 11

2.3. Quality Management..16

2.4. Organization and Personnel...19

2.5. Premises and Facilities..25

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Chapter 3 Good Manufacturing Practice for Sterile Pharmaceutical Products.. 75

3.1. Scope of Application. 75

3.2. Glossary.. 75

3.3. Principles. 76

3.4. Cleanliness Levels and Monitoring.. 77

3.5. Operation Techniques for Isolation.. 81

Chapter 4 Good Manufacturing Practices for Active Pharmaceutical Ingredients. 96

4.1. Applicable Scope.. 96

4.2. Glossary.. 96

4.3. Buildings and facilities . 97

4.4. Equipments 97

4.5. Materials.. 98

Chapter 5 Good Manufacturing Practice for Biological Products.. 112

5.1. Scope of Application..112

5.2. Glossary  .112

5.3. Principles. 112

5.4. Personnel 113

5.5. Premises and Equipments.114

Chapter 6 Good Manufacturing Practice for Blood Products 120

6.1. Applicable Scope..120

6.2. Principles. 120

6.3. Personnel 120

6.4. Premises and Equipments... 121

6.5. Raw Plasma.. 122

Chapter 7 Good Manufacturing Practice for Traditional Chinese Medicine Preparations. 126

7.1. Scope of Application 126

7.2. Glossary.. 126

7.3. Principles  ...126

7.4. Organization and Personnel... 126

7.5. Premises and Facilities .127

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