Luận văn The challenges for implementation of good manufacturing practices by local pharmaceutical manufactures in vietnam

Table of Contents Chapter Title Page  Title Page i Acknowledgement ii Abstract iii Table of Contents iv List of Abbreviations v 1. Introduction 1 2. Theoretical Review 62.1 Quality Assurance in Pharmaceutical industry 62.2 ASEAN GMP 102.3 GMP in comparison with ISO 9000 series 122.4 Pros and cons in implementing quality standards 17 3. Pharmaceutical Industry and GMP implementation in Vietnam 193.1 Overview of pharmaceutical industry in Vietnam 193.2 Government policies towards GMP implementation 223.3 Vietnam GMP guidelines 243.4 Major challenges faced by firms towards implementing GMP 243.5 Government's responsibilities in supporting firms’ GMP compliance 30 4. Conclusions and Recommendations 314.1 Conclusions 314.2 Recommendations 324.2.1 To firms 324.2.2 To government 394.2.3 To further studies 42 5. References 43 6. Appendices A. ASEAN GMP 44 B. A typical Organizational Structure of GMP-approved firm 51 C. ASEAN and other National GLP and GMP Authorities 52 D. Web-sites relating to some of GMP regulations 54E. List of local pharmaceutical manufacturers and 55 their relevant data55F. Circular 12 BYT-QD providing a guide 64 for implementing ASEAN GMPG. Interviewees 67

Table of Contents

Chapter Title Page

Title Page i

Acknowledgement ii

Abstract iii

Table of Contents iv

List of Abbreviations v

1. Introduction 1

2. Theoretical Review 6

2.1 Quality Assurance in Pharmaceutical industry 6

2.2 ASEAN GMP 10

2.3 GMP in comparison with ISO 9000 series 12

2.4 Pros and cons in implementing quality standards 17

3. Pharmaceutical Industry and GMP implementation in Vietnam 19

3.1 Overview of pharmaceutical industry in Vietnam 19

3.2 Government policies towards GMP implementation 22

3.3 Vietnam GMP guidelines 24

3.4 Major challenges faced by firms towards implementing GMP 24

3.5 Government's responsibilities in supporting firms’ GMP compliance 30

4. Conclusions and Recommendations 31

4.1 Conclusions 31

4.2 Recommendations 32

4.2.1 To firms 32

4.2.2 To government 39

4.2.3 To further studies 42

5. References 43

6. Appendices

A. ASEAN GMP 44

B. A typical Organizational Structure of GMP-approved firm 51

C. ASEAN and other National GLP and GMP Authorities 52

D. Web-sites relating to some of GMP regulations 54

E. List of local pharmaceutical manufacturers and 55

their relevant data55

F. Circular 12 BYT-QD providing a guide 64

for implementing ASEAN GMP

G. Interviewees 67

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