[FONT="]Table of Contents

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Chapter Title Page

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[FONT="] [FONT="]Title Page i

[FONT="] Acknowledgement ii

[FONT="] Abstract iii

[FONT="] Table of Contents iv

[FONT="] List of Abbreviations v

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[FONT="]1. Introduction 1

[FONT="]2. Theoretical Review 6

[FONT="]2.1 Quality Assurance in Pharmaceutical industry 6

[FONT="]2.2 [FONT="]ASEAN GMP 10

[FONT="]2.3 [FONT="]GMP in comparison with ISO 9000 series 12

[FONT="]2.4 Pros and cons in implementing quality standards 17

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[FONT="]3. Pharmaceutical Industry and GMP implementation in Vietnam 19

[FONT="]3.1 Overview of pharmaceutical industry in Vietnam 19

[FONT="]3.2 [FONT="]Government policies towards GMP implementation 22

[FONT="]3.3 [FONT="]Vietnam GMP guidelines 24

[FONT="]3.4 [FONT="]Major challenges faced by firms towards implementing GMP 24

[FONT="]3.5 [FONT="]Government's responsibilities in supporting firms’ GMP compliance 30

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[FONT="]4. [FONT="]Conclusions and Recommendations 31

[FONT="]4.1 [FONT="]Conclusions 31

[FONT="]4.2 [FONT="]Recommendations 32

[FONT="]4.2.1 [FONT="]To firms 32

[FONT="]4.2.2 [FONT="]To government 39

[FONT="]4.2.3 [FONT="]To further studies 42

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[FONT="]5. References 43

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[FONT="]6. Appendices

[FONT="] A. ASEAN GMP 44

[FONT="] B. A typical Organizational Structure of GMP-approved firm 51

[FONT="] C. ASEAN and other National GLP and GMP Authorities 52

[FONT="] D. Web-sites relating to some of GMP regulations 54

[FONT="]E. [FONT="]List of local pharmaceutical manufacturers and 55

[FONT="] their relevant data55

[FONT="]F. [FONT="]Circular 12 BYT-QD providing a guide 64

[FONT="] for implementing ASEAN GMP

[FONT="]G. Interviewees 67

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