Latest Guide to Chinese Pharmaceutical GMP Regulations

Published : July 2012
No. of Pages : 135

Price:

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.

The Chinese health authorities, the Ministry of Health (MOH) issued the latest Good Manufacturing Practice for Drugs (2010 Revision), which came into effect as of March 1, 2011, after five years of amendments and two rounds of public consultation. Since its first promulgation in 1988, Chinese Good Manufacturing Practice for Drugs (GMP) has experienced two amendments in 1992 and 1998 respectively. The latest version of GMP follows up the main principles of WHO GMP, adopting advanced international experiences and in light of the actual conditions of China. The latest version of GMP consists of 14 chapters and 313 articles. The Chinese pharmaceutical authorities, the Sate Food and Drug Administration (SFDA) issued five documents as annexes of the latest GMP, that is, Good Manufacturing Practice for Sterile Pharmaceutical Products, Good Manufacturing Practice for Active Pharmaceutical Ingredients, Good Manufacturing Practice for Biological Products, Good Manufacturing Practice for Blood Products, and Good Manufacturing Practice for Traditional Chinese Medicine Preparations, also came into effect as of the same time with the latest version of GMP.

The newly entered foreign-funded pharmaceutical manufacturers and the newly built (reconstructed or extended) projects and workshops of foreign-funded pharmaceutical manufacturers in China must comply with the requirements of the latest version of GMP regulations. The existing foreign-funded pharmaceutical manufacturers will be granted a transition period of no more than five years and should come up to the requirements of the latest version of GMP regulations by category and stage by stage in accordance with the product risk level.

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.

There are many differences between the Chinese GMPs and the EU, US GMPs. Like EU GMP, the latest Chinese GMPs set forth the requirement of establish a quality system, with their own quality objectives, applying all of requirements on safety, efficacy and quality control related with drug registration to the whole process of drug production. EU and the latest Chinese GMPs introduce the concepts of Quality Assurance in the same way, but US GMPs does not establish the requirement of having a quality system, ( even though this concepts can be understood with the whole reading of 21 CFR Parts 210 & 211). Again the latest Chinese GMPs and EU GMPs introduce clearly the Risk Management Approach according to ICH Q 9 concepts. Conversely, 21 CFR does not mention these concepts which are much newer than last revision of US GMPs. The latest Chinese GMPs are much more explicit in some sections, for example, detailing SOP distribution and withdrawal, the use of food grade lubricant when possible, the existence of a maintenance progamme, existence of specific cleaning methods, existence of equipment status identification or the existence of calibration labels. Moreover, the latest Chinese GMPs includes requirements on the water quality (at least use drinking waters). These aspects are all included in ICH Q7A( EU GMPs Part II) – Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, but not in EU GMPs Part I or 21 CFR PART 210 & 211.

One of the biggest differences between the Chinese GMPs and the EU, US GMPs is that the Chinese pharmaceutical authorities particularly emphasis on the role of personnel in production process. The latest Chinese GMPs identifies not only the responsibility of top management personnel for the implementation of quality objectives (ICH Q 10 concepts), but also the minimum qualifications for the person in charge of production management (a college degree in pharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a pharmacist’s license), with at least three years of practical experience in pharmaceutical production and quality management, among which at least one year in production management), quality unit (a college degree in pharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a pharmacist’s license), with at least five years of practical experience in pharmaceutical production and quality management, among which at least one year in quality management), and authorized person (a college degree in pharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a pharmacist’s license), with at least five years of practical experience in pharmaceutical production and quality management, with work experience in in-process control and quality testing). US and EU GMPs does not include any consideration about it. US GMPs is the only one requiring consultant’s qualification that is their qualification (curriculums) should be retained. In one word, numerous differences exist between the Chinese GMPs and the EU, US GMPs.

The organizations of this guidebook are arranged as follows. Chapter 2 provides an overview of Good Manufacturing Practice (GMP) for Drugs, which are comprehensive regulations to regulate the manufacturing and quality management of drugs in whole process for all drug manufacturing. Chapter 3 introduces the details of Good Manufacturing Practice for Sterile Pharmaceutical Products. Chapter 4 introduces the Good Manufacturing Practice for Active Pharmaceutical Ingredients in detail. Chapter 5 provides the detailed comprehensive guidance of Good Manufacturing Practice for Biological Products. Chapter 6 addresses the comprehensive knowledge of Good Manufacturing Practice for Blood Products, and the Chapter 7 elaborates the comprehensive knowledge of Good Manufacturing Practice for Traditional Chinese Medicine Preparations.

The audiences of this guidebook are overseas pharmaceutical companies and multinational pharmaceutical companies wishing to entry into the Chinese drug market, and their senior executive officers engaging in regulatory affairs expect to understand the latest Chinese Pharmaceutical GMP regulations. After have skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Pharmaceutical GMP regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can help guide overseas pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese drug market, and smoothly operate their companies in China.

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

Table of Contents 1

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
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. Principles49
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 an 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

Latest Guide to Chinese Pharmaceutical GMP Regulations

Published By: Access China Management Consulting Ltd

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