Thạc Sĩ The challenges for implementation of good manufacturing practices by local pharmaceutical manufactur

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