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Latest Guide to Chinese Pharmaceutical GMP Regulations

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China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2011, sales on the Chinese drug market have reached RMB 1550 billion (about US$246 billion), an increase of 7.08 fold over 2000 level. 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 25 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.

Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which not only gave a fillip to the imported drugs from overseas pharmaceutical manufacturers but also attracted overseas investors to establish the foreign investment enterprises, including “Sino-foreign equity joint ventures (EJV)”, “Sino—foreign cooperative joint ventures (CJV)” and “wholly foreign-owned enterprises (WFOE)” in China. Since the 1980s, thousands of foreign pharmaceutical companies have entered the Chinese drug market. Today, multinational pharmaceutical companies have over 1140 active joint ventures and foreign-owned enterprises in China and most giants of global pharmaceutical industry have a Chinese presence, including AstraZeneca, Pfizer, Roche, Novartis, Merck & Co, Eli Lilly & Company, GlaxoSmithKline and Johnson & Johnson. By 2011, sales of drugs manufactured and produced by the foreign-funded pharmaceutical manufacturers and producers in China have shared over one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for foreign-funded pharmaceutical companies, and multinational pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market.

To enter such a lucrative drug market, the overseas pharmaceutical manufacturers and producers must conform to Chinese Good Manufacturing Practice (GMP) regulations for pharmaceuticals. Therefore, a comprehensive and thorough knowledge of the latest Chinese Pharmaceutical GMP regulations has been become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese drug market, so more and more overseas pharmaceutical companies and multinational pharmaceutical companies, and their senior executive officers engaging in regulatory affairs expect to understand the latest Chinese Pharmaceutical GMP regulations.

 

Guidebook Highlights

An overview of Good Manufacturing Practice (GMP) for Drugs.
The details of Good Manufacturing Practice for Sterile Pharmaceutical Products.
The Good Manufacturing Practice for Active Pharmaceutical Ingredients in detail.
The detailed comprehensive guidance of Good Manufacturing Practice for Biological Products.
The comprehensive knowledge of Good Manufacturing Practice for Blood Products.
The comprehensive knowledge of Good Manufacturing Practice for Traditional Chinese Medicine Preparations

 

Table of Contents :

 

Chapter 1 Introduction .. 5
Chapter 2 An Overview of Good Manufacturing Practice (GMP) for Drugs11
2.1. General 11
2.2. Glossary.. 11
2.3. Quality Management 16
2.3.1. Principles .. 16
2.3.2. Quality Assurance ...16
2.3.3. Quality Control ..18
2.3.4 Quality Risk Management 19
2.4. Organization and Personnel ...19
2.4.1. Principles 19
2.4.2. Key Personnel 20
2.4.3. Training 23
2.4.4. Personnel Hygiene 24
2.5. Premises and Facilities ...25
2.5.1. Principles 25
2.5.2. Production Area .. .26
2.5.3. Storage Areas 28
2.5.4. Quality Control Areas ..29
2.5.5. Ancillary Areas .29
2.6. Equipment .30
2.6.1. Principles 30
2.6.2. Design and Installation ..30
2.6.3. Maintenance and Repair .31
2.6.4. Usage and Cleaning .31
2.6.5. Calibration .32
2.6.6. Water for Pharmaceutical Use .33
2.7. Materials and Products 33
2.7.1. Principles .. 33
2.7.2. Starting Materials 35
2.7.3. Intermediate and Bulk Products .36
2.7.4. Packaging Materials ...36
2.7.5. Finished Products ...37
2.7.6. Controlled Materials and Products .37
2.7.7. Other Special Provisions .. 37
2.8. Qualification and Validation ..39
2.9. Documentation Management 41
2.9.1. Principles ...41
2.9.2. Specifications . .42
2.9.3. Master Manufacturing Documents ..43

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