Chinese Pharmaceutical GMP Regulations Examined by Access China Management Consulting in New Guide Available at MarketPublishers.com

New market research report "Latest Guide to Chinese Pharmaceutical GMP Regulations" elaborated by Access China Management Consulting has been recently published by Market Publishers Ltd. According to the report, by 2011 sales on the Chinese drug market have reached about US$246 billion, an increase of 7.08 fold over 2000 level.

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London, UK (PRWEB) July 18, 2012

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.

New market research report "Latest Guide to Chinese Pharmaceutical GMP Regulations" elaborated by Access China Management Consulting has been recently published by Market Publishers Ltd.

Report Details:

Title: Latest Guide to Chinese Pharmaceutical GMP Regulations
Published: July, 2012
Pages: 135
Price: US$ 750
http://marketpublishers.com/report/medicine_pharmaceuticals_biotechnology/healthcare_equipment_services/latest_guide_to_chinese_pharmaceutical_gmp_regulations.html

The report provides an in-depth analytical picture of the China pharmaceuticals market and GMP regulations. It features:

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

Report Contents:

CHAPTER 1 INTRODUCTION

CHAPTER 2 AN OVERVIEW OF GOOD MANUFACTURING PRACTICE (GMP) FOR DRUGS..

2.1. General
2.2. Glossary
2.3. Quality Management
2.3.1. Principles
2.3.2. Quality Assurance
2.3.3. Quality Control
2.3.4 Quality Risk Management
2.4. Organization and Personnel
2.4.1. Principles
2.4.2. Key Personnel
2.4.3. Training
2.4.4. Personnel Hygiene
2.5. Premises and Facilities
2.5.1. Principles
2.5.2. Production Area
2.5.3. Storage Areas
2.5.4. Quality Control Areas
2.5.5. Ancillary Areas
2.6. Equipment
2.6.1. Principles
2.6.2. Design and Installation
2.6.3. Maintenance and Repair
2.6.4. Usage and Cleaning
2.6.5. Calibration
2.6.6. Water for Pharmaceutical Use
2.7. Materials and Products
2.7.1. Principles
2.7.2. Starting Materials
2.7.3. Intermediate and Bulk Products
2.7.4. Packaging Materials
2.7.5. Finished Products
2.7.6. Controlled Materials and Products
2.7.7. Other Special Provisions
2.8. Qualification and Validation
2.9. Documentation Management
2.9.1. Principles
2.9.2. Specifications
2.9.3. Master Manufacturing Documents
2.9.4. Batch Processing Records
2.9.5. Batch Packaging Record
2.9.6. Operation Procedures and Records
2.10. Production Management
2.10.1. Principles
2.10.2. Prevention of Contamination and Cross-contamination
in Production
2.10.3. Processing Operations
2.10.4. Packaging Operations
2.11. Quality Control and Quality Assurance
2.11.1. Management of Quality Control Laboratories
2.11.2. Release of the Materials and Products
2.11.3. On-going Stability Program
2.11.4. Change Control
2.11.5. Deviation Handling
2.11.6. Corrective Actions and Preventive Actions
2.11.7. Supplier Assessment and Approval
2.11.8. Product Quality Review
2.11.9. Complaints and Adverse Drug Reaction Reports
2.12. Contract Manufacture and Analysis
2.12.1. Principles
2.12.2. The Contract Giver
2.12.3.The Contract Acceptor
2.12.4. The Contract
2.13. Product Distribution and Recalls
2.13.1. Principles
2.13.2. Distribution
2.13.3. Recalls
2.14. Self Inspections
2.14.1. Principles
2.14.2. Self Inspections

CHAPTER 3 GOOD MANUFACTURING PRACTICE FOR STERILE PHARMACEUTICAL PRODUCTS

3.1. Scope of Application
3.2. Glossary
3.3. Principles
3.4. Cleanliness Levels and Monitoring
3.5. Operation Techniques for Isolation
3.6. Operation Techniques for Blowing, Filling, Sealing
3.7. Personnel
3.8. Premises
3.9. Equipment
3.10. Sterilization
3.11. Production Management
3.12. Sterilization Process
3.13. Sterilization Methods
3.14. Finishing of Sterile Products
3.15. Quality Control

CHAPTER 4 GOOD MANUFACTURING PRACTICES FOR ACTIVE PHARMACEUTICAL INGREDIENTS

4.1. Applicable Scope
4.2. Glossary
4.3. Buildings and facilities
4.4. Equipments
4.5. Materials
4.6. Validation
4.6.1. Validation Approach
4.6.2. Validation Protocol
4.6.3. Cleaning Validation
4.7. Documentation

More new market research reports by the publisher can be found at Access China Management Consulting page.


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