The challenges for implementation of good manufacturing practices by local pharmaceutical manufacturers in Vietnam | |
| Author | Duong To Dung |
| Call Number | AIT RSPR no. SM-01-100 |
| Subject(s) | Quality assurance--Vietnam Pharmaceutical industry--Vietnam |
| Note | A research study submitted in partial fulfillment of the requirements for the degree of Master of Business Administration, School of Management |
| Publisher | Asian Institute of Technology |
| Series Statement | Research studies project report ; no. SM-01-100 |
| Abstract | Good Manufacturing Practices (GMP) guidelines or regulations for pharmaceutical, food, cosmetic, and some other industries aim at ensuring that products are consistently produced and controlled to the quality standards appropriate to their intended uses and as required by the marketing authorizations or product specifications. In pharmaceutical industry, GMP is the most fundamental element of Quality Assurance and internationally recognized. Basic standards of GMP have been published by the World Health Organization (WHO). Nevertheless, many multi-national companies normally work to the more demanding standards of GMP imposed by regulatory agencies in the European Union and the United States Food and Drug Administration (FDA) as well as their own internal or national GMP guidelines. In most developed countries, GMP has become force of law, while in Vietnam, GMP guidelines that based on ASEAN QMP guidelines are not enforceable. Therefore, putting GMP into regulation is the concern of Vietnam's Ministry of Health, as there are existed constraints relating to the current local circumstances as well as local pharmaceutical manufacturers' capabilities. Thus, this research identifies and describes the challenges and difficulties faced by pharmaceutical manufacturers, especially local firms in Vietnam towards implementing GMP. These challenges can be classified into two categories: internal factors and external factors. Internal factors comprise the financial shortage, qualified-personnel shortage and inability in information accessing. External factors include government lagged and inappropriate policies, customer attitudes and behaviors, and rivals' influences. |
| Year | 2001 |
| Corresponding Series Added Entry | Asian Institute of Technology. Research studies project report ; no. SM-01-100 |
| Type | Research Study Project Report (RSPR) |
| School | School of Management |
| Department | Other Field of Studies (No Department) |
| Academic Program/FoS | Master of Business Administration (MBA) (Publication code=SM) |
| Chairperson(s) | Khang, Do Ba; |
| Examination Committee(s) | Lee, Sang-Kon ;Ramachandran, N.; |
| Scholarship Donor(s) | The Government of Switzerland/ Swiss Development Cooperation (SA V) ; |
| Degree | Research Studies Project Report (M.B.A.) - Asian Institute of Technology, 2001 |