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Latest Guide to Chinese Pharmaceutical GMP Regulations
Publication Date Jul 2015
Product Type Report
Pages 135
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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.
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 2012, 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.

Scope
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. It 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, 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, as well as the comprehensive knowledge of Good Manufacturing Practice for Traditional Chinese Medicine Preparations.

Reasons to Buy
• 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.
• Non-Chinese pharmaceutical consultative companies engaging in agent service for application of foreign pharmaceutical investment projects with the Chinese government authorities in China.
• Non-Chinese universities, colleges, academic & research institutions
• Non-Chinese university library, public library.
• Non-Chinese Chamber of Commerce.

Key Highlights
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 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
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

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