Chinese Pharmaceutical GMP Regulations |
a comprehensive and thorough knowledge of the Chinese pharmaceutical GMP regulations to guide overseas pharmaceutical companies to achieve a successful entry into the Chinese lucrative drug market. |
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Contact Information |
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Access China Management Consulting Ltd
Nanjing
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China
86-510-85759572
labwu.zengxian.wu@gmail.com
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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.
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.
However, there is no a guidebook of comprehensive and thorough knowledge of the Chinese GMP regulations for pharmaceuticals until now. Under such circumstance, Access China Management Consulting Ltd published this Latest Guide to Chinese Pharmaceutical GMP Regulations. The aim of this guidebook is to provide a comprehensive and thorough knowledge of the latest Chinese 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.
Who should buy this report?
• Foreign pharmaceutical companies wishing to enter a lucrative drug market in China.
• Foreign pharmaceutical companies interested in understanding the latest Chinese Pharmaceutical GMP regulations.
• Senior executive officers engaging in regulatory affairs for application and approval of foreign pharmaceutical investment projects in China.
• Senior executive officers engaging in regulatory affairs for quality control, quality assurance, and production management.
Published Date: July 20, 2012
Page Count: 135
Unit Price: US$ 750
Site License: US$3500
Format: Electronic PDF copy
Table of Contents. 1
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
2.3.1. 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
2.9.4. Batch Processing Records.45
2.9.5. Batch Packaging Record.46
2.9.6. Operation Procedures and Records.48
2.10. Production Management.49
2.10.1. Principles.49
2.10.2. Prevention of Contamination and Cross-contamination
in Production .50
2.10.3. Processing Operations.51
2.10.4. Packaging Operations.52
2.11. Quality Control and Quality Assurance.53
2.11.1. Management of Quality Control Laboratories.53
2.11.2. Release of the Materials and Products. 60
2.11.3. On-going Stability Program .61
2.11.4. Change Control. 63
2.11.5. Deviation Handling. 64
2.11.6. Corrective Actions and Preventive Actions. 65
2.11.7. Supplier Assessment and Approval .66
2.11.8. Product Quality Review.67
2.11.9. Complaints and Adverse Drug Reaction Reports.69
2.12. Contract Manufacture and Analysis. 70
2.12.1. Principles.70
2.12.2. The Contract Giver.70
2.12.3. The Contract Acceptor.71
2.12.4. The Contract.71
2.13. Product Distribution and Recalls.72
2.13.1. Principles.72
2.13.2. Distribution.72
2.13.3. Recalls.72
2.14. Self Inspections.73
2.14.1. Principles.73
2.14.2. Self Inspections.73
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
3.6. Operation Techniques for Blowing, Filling, Sealing. 82
3.7. Personnel.83
3.8. Premises. 84
3.9. Equipment.86
3.10. Sterilization.86
3.11. Production Management.87
3.12. Sterilization Process.90
3.13. Sterilization Methods. 91
3.14. Finishing of Sterile Products. 94
3.15. Quality Control. 95
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
4.6. Validation. 99
4.6.1. Validation Approach. 99
4.6.2. Validation Protocol.100
4.6.3. Cleaning Validation.101
4.7. Documentation.102
4.8. Production Management .103
4.8.1. Production Operations.103
4.8.2. In-process Sampling and Controls.104
4.8.3. Removal or Inactivation of Viruses.104
4.8.4. Blending batches of intermediates or APIs.105
4.8.5. Principles of Division of Production Batches.106
4.8.6. Contamination Control.106
4.8.7. Packaging of APIs and intermediates.106
4.9. Change Control.107
4.9.1. Reprocessing.107
4.9.2. Reworking.107
4.9.3. Recovery of Materials and Solvents. 108
4.10. Quality Management. 108
4.10.1. Continued Stability Investigation of APIs.109
4.11. Special requirements of traditional fermentation process to produce APIs .109
4.11. 1. Process Control.109
4.11.2. Cell Culture or Fermentation.110
4.11.3. Harvest, Separation and Purification. 111
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
5.6. Animal Housing and Related Matters. 116
5.7. Production Management. 117
5.8. Quality Management. 119
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
6.6. Production and Quality Control. 124
6.7. Operation Procedures for Handling Unqualified Raw Plasma,
Intermediate Products and Finished Products. 125
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
7.6. Materials .128
7.7. Document Management. 130
7.8. Production Management. 131
7.9. Quality Management .132
7.10. Contract Production.133
For more information, visit: http://www.accesschinainfo.com
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