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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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Vietnam GMP is basically built followed ASEAN GMP, however, it is only true for the general guidelines, while the practical and specific procedural guidelines are established for the appropriateness of the local circumstances. For detailed and specific requirements of Vietnam GMP, two key persons in Vietnam Ministry of Health can be contacted via the addresses given in the appendix G.
3.4 Major challenges faced by firms towards implementing GMP standards
Up to the end of the first quarter of the year 2000, Vietnam has only 15 pharmaceutical factories that are recognized as meeting the ASEAN GMP standards, accounting 13.4% of total pharmaceutical manufacturers in Vietnam. (Ministry of Health at a Friday meeting in HCMC to review the implementation of GMP standards by drug factories nationwide on April 10th, 2000). These include eight all-local producers, and seven foreign-owned companies.
In reaching the target of 100% GMP compliance in the year 2003, there must be some dramatic changes happened, both in companies’ efforts and government’s supports to overcome the existing challenges. Thus, before mentioning how to overcome those challenges, they must be addressed specifically. Hence, what are the challenges faced by firms in implementing GMP standards?
The challenges faced by pharmaceutical manufacturers in Vietnam in attaining GMP compliance are divided into two groups of internal factors and external factors.
3.4.1 Internal factors
Internal factors consist of three major sources mentioned hereunder, which are the financial shortage, the qualified-personnel shortage in terms of both GMP-relating as well as technical manpower, and finally the inconvenience or incapability of firms in accessing the needed information.
Financial challenges
According to the Dr. Quang, Vice Director of the Institute of Drug Quality Control, Ho Chi Minh city, Vietnam, approximately two million of U.S dollars per production line is needed for firm to spend on GMP implementation. That amount is a considering large amount for local pharmaceutical manufacturers, especially the small enterprises. Local pharmaceutical manufacturers’ revenues in 1999 are summarized in the graph hereunder.
Figure 3.1: Local pharmaceutical manufacturers’ revenues in 1999
Note: Data collected from Vietnam’s Ministry of Commerce
A list of firms and their relevant data can be referred in the appendix E
From the above graph, there are only eight firms having the revenues exceeding two million of U.S.$, accounting less than 30% of total mentioned There are more smaller local pharmaceutical firms which are not included in the list due to two main reasons:
Not directly produce drugs
Too small compared to others
local pharmaceutical manufacturers. There is only one firm having revenue exceeding ten million of U.S.$, that is the National Pharmaceutical Co. No.1. With revenues exceeding eight million of U.S.$, there is an additional company qualified. In general, assume that a company wanting to implement GMP (investment of two million U.S.$ per production line) needs to have revenue doubling the initiative investment on GMP, thus, there are only 4 companies qualified, accounting less than 20% of total considered local firms.
Lack of qualified personnel
Lack of GMP-trained personnel:
In Vietnam, the number of persons who was properly trained of GMP is insufficient. Foreign-owned firms usually send their personnel abroad for GMP training while it is hard for state-owned companies to do so due to the limited financial budgets. According to the statistics of the Ministry of Health, up to the second quarter of the year 2000, there are only twenty local pharmacists trained formally by Australian trainers on GMP (Saigon Times, August 22nd, 2000). Besides, there are few officers of the Ministry of Health are trained on GMP and attended meetings relating to ASEAN GMP topics. Aside form those, many persons are trained locally and informally of general information about GMP for a short period. Thus, they are not qualified as key persons in promoting GMP implementation process.
Lack of highly technical-skilled personnel:
In GMP guidelines, there are many well-defined and rather strict requirements that need to be executed properly by qualified technical staffs, who are usually qualified pharmacists. As common actualities for firms around the world, it is quite difficult to be able to recruit the well-qualified personnel, and it is much harder to retain them. That reality is especially true for state-owned firms wherein the improper organizational rules or bureaucracy procedures still exist.
Difficulties in Information Accessing:
It is a common circumstance in Vietnam that firms, especially state-owned and small enterprises, face many obstacles and challenges in finding the necessary information for doing their businesses. It is even truer for searching the information relating to GMP as GMP is rather new in Vietnam for about four or five years. Usually firms are eager to implement GMP, however, they do not know what to do, where to commence, to what extent, and alike. In the guidelines, regulations, circulars All of the guidelines, regulations, circulars and the like can be found at the Vietnam Ministry of Health at the following address:
138A Giang Vo Street
Hanoi, Vietnam
Tel: (844) 8461525
Fax: (844) 8234758
alike, there is no specific detail guiding firms on a step-by-step basis towards implementing GMP. Though, this might be considered as an external factor. Nevertheless, it is included in internal factors for accentuating firm’s insufficient investment on maintaining and improving their intangible assets.
Normally, at this moment, email is popular for firms. However, Internet and its robust information resources are still beyond major firms’ reach mainly due to the two reasons: there is no needed information available on the Internet, and the high Internet accessing fee. (Currently, the Internet accessing fee through phone line is approximately U.S.$ 1.5 per hour).
3.4.2 External factors
Three main causes are believed to be factors that obstruct firms’ GMP-implementation capabilities. They are the lack of updated as well as the proper governmental policies towards encouraging firms’ GMP compliance, consumers’ behaviors and attitudes such as self-directing habits in buying medicines, plus their lacking of awareness of quality standards such as GMP standards, and finally the rivals’ effects such as unbalanced and unsound competition, price competition and the like.
Governmental policies:
Regulations as well as guidelines are issued laggardly, inconsistently and non-synchronously, bringing firms many obstacles and confusions in deciding what to do in implementing GMP standards. Referring to all of the issued guidelines, regulations, circulars and the like, which are relating to GMP, there is no specific guidance on how to successfully implement GMP standards or the listed pitfalls, key points in GMP implementation. Moreover, referring to session 3.2, it can be seen that there is nearly one and a half year lagged after the issuing of the requirement of GMP compliance in all pharmaceutical manufacturers, the privileges for GMP-complied firms was mentioned formally. Thus, firms have not many motives for implementing GMP that costs them significantly at the initial period.
Lacking of clear favorable conditions reserved for GMP-complied firms as well as of a proper and effective mechanism for supplying the essential and necessary information for firms in order to encourage GMP compliance. As mentioned in session 3.2, the followings are the granted privileges for GMP-complied firms:
Be allowed to print an additional sentence of “GMP-approved Company” in the label.
Be granted some favors in manufacturing the exports.
Be allowed to cooperate and to be franchised with major well-known pharmaceutical manufacturers in the world for some kinds of products.
Be prioritized in participating in bidding both at national and international level, to supply pharmaceuticals for national health programs.
Be favored in supplying the essential pharmaceuticals for hospitals as well as health programs, which funded by governmental funds or international aids.
Be privileged in approving the production registration, including the pharmaceuticals belonging to the list of limited-granting products.
(Note: the above favors for GMP-complied firms are entirely quoted from the letter No. 284/QLD issued on January 14th, 1998 by the Ministry of Health on favorable conditions for GMP-approved pharmaceutical factories).
The ambiguousness of these favors are analyzed hereunder:
Be allowed to print an additional sentence of “GMP-approved Company” in the label. What does it be...
Download miễn phí 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 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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Tóm tắt nội dung:
tation. However, the mentioned GMP is only guideline but not regulation.Vietnam GMP is basically built followed ASEAN GMP, however, it is only true for the general guidelines, while the practical and specific procedural guidelines are established for the appropriateness of the local circumstances. For detailed and specific requirements of Vietnam GMP, two key persons in Vietnam Ministry of Health can be contacted via the addresses given in the appendix G.
3.4 Major challenges faced by firms towards implementing GMP standards
Up to the end of the first quarter of the year 2000, Vietnam has only 15 pharmaceutical factories that are recognized as meeting the ASEAN GMP standards, accounting 13.4% of total pharmaceutical manufacturers in Vietnam. (Ministry of Health at a Friday meeting in HCMC to review the implementation of GMP standards by drug factories nationwide on April 10th, 2000). These include eight all-local producers, and seven foreign-owned companies.
In reaching the target of 100% GMP compliance in the year 2003, there must be some dramatic changes happened, both in companies’ efforts and government’s supports to overcome the existing challenges. Thus, before mentioning how to overcome those challenges, they must be addressed specifically. Hence, what are the challenges faced by firms in implementing GMP standards?
The challenges faced by pharmaceutical manufacturers in Vietnam in attaining GMP compliance are divided into two groups of internal factors and external factors.
3.4.1 Internal factors
Internal factors consist of three major sources mentioned hereunder, which are the financial shortage, the qualified-personnel shortage in terms of both GMP-relating as well as technical manpower, and finally the inconvenience or incapability of firms in accessing the needed information.
Financial challenges
According to the Dr. Quang, Vice Director of the Institute of Drug Quality Control, Ho Chi Minh city, Vietnam, approximately two million of U.S dollars per production line is needed for firm to spend on GMP implementation. That amount is a considering large amount for local pharmaceutical manufacturers, especially the small enterprises. Local pharmaceutical manufacturers’ revenues in 1999 are summarized in the graph hereunder.
Figure 3.1: Local pharmaceutical manufacturers’ revenues in 1999
Note: Data collected from Vietnam’s Ministry of Commerce
A list of firms and their relevant data can be referred in the appendix E
From the above graph, there are only eight firms having the revenues exceeding two million of U.S.$, accounting less than 30% of total mentioned There are more smaller local pharmaceutical firms which are not included in the list due to two main reasons:
Not directly produce drugs
Too small compared to others
local pharmaceutical manufacturers. There is only one firm having revenue exceeding ten million of U.S.$, that is the National Pharmaceutical Co. No.1. With revenues exceeding eight million of U.S.$, there is an additional company qualified. In general, assume that a company wanting to implement GMP (investment of two million U.S.$ per production line) needs to have revenue doubling the initiative investment on GMP, thus, there are only 4 companies qualified, accounting less than 20% of total considered local firms.
Lack of qualified personnel
Lack of GMP-trained personnel:
In Vietnam, the number of persons who was properly trained of GMP is insufficient. Foreign-owned firms usually send their personnel abroad for GMP training while it is hard for state-owned companies to do so due to the limited financial budgets. According to the statistics of the Ministry of Health, up to the second quarter of the year 2000, there are only twenty local pharmacists trained formally by Australian trainers on GMP (Saigon Times, August 22nd, 2000). Besides, there are few officers of the Ministry of Health are trained on GMP and attended meetings relating to ASEAN GMP topics. Aside form those, many persons are trained locally and informally of general information about GMP for a short period. Thus, they are not qualified as key persons in promoting GMP implementation process.
Lack of highly technical-skilled personnel:
In GMP guidelines, there are many well-defined and rather strict requirements that need to be executed properly by qualified technical staffs, who are usually qualified pharmacists. As common actualities for firms around the world, it is quite difficult to be able to recruit the well-qualified personnel, and it is much harder to retain them. That reality is especially true for state-owned firms wherein the improper organizational rules or bureaucracy procedures still exist.
Difficulties in Information Accessing:
It is a common circumstance in Vietnam that firms, especially state-owned and small enterprises, face many obstacles and challenges in finding the necessary information for doing their businesses. It is even truer for searching the information relating to GMP as GMP is rather new in Vietnam for about four or five years. Usually firms are eager to implement GMP, however, they do not know what to do, where to commence, to what extent, and alike. In the guidelines, regulations, circulars All of the guidelines, regulations, circulars and the like can be found at the Vietnam Ministry of Health at the following address:
138A Giang Vo Street
Hanoi, Vietnam
Tel: (844) 8461525
Fax: (844) 8234758
alike, there is no specific detail guiding firms on a step-by-step basis towards implementing GMP. Though, this might be considered as an external factor. Nevertheless, it is included in internal factors for accentuating firm’s insufficient investment on maintaining and improving their intangible assets.
Normally, at this moment, email is popular for firms. However, Internet and its robust information resources are still beyond major firms’ reach mainly due to the two reasons: there is no needed information available on the Internet, and the high Internet accessing fee. (Currently, the Internet accessing fee through phone line is approximately U.S.$ 1.5 per hour).
3.4.2 External factors
Three main causes are believed to be factors that obstruct firms’ GMP-implementation capabilities. They are the lack of updated as well as the proper governmental policies towards encouraging firms’ GMP compliance, consumers’ behaviors and attitudes such as self-directing habits in buying medicines, plus their lacking of awareness of quality standards such as GMP standards, and finally the rivals’ effects such as unbalanced and unsound competition, price competition and the like.
Governmental policies:
Regulations as well as guidelines are issued laggardly, inconsistently and non-synchronously, bringing firms many obstacles and confusions in deciding what to do in implementing GMP standards. Referring to all of the issued guidelines, regulations, circulars and the like, which are relating to GMP, there is no specific guidance on how to successfully implement GMP standards or the listed pitfalls, key points in GMP implementation. Moreover, referring to session 3.2, it can be seen that there is nearly one and a half year lagged after the issuing of the requirement of GMP compliance in all pharmaceutical manufacturers, the privileges for GMP-complied firms was mentioned formally. Thus, firms have not many motives for implementing GMP that costs them significantly at the initial period.
Lacking of clear favorable conditions reserved for GMP-complied firms as well as of a proper and effective mechanism for supplying the essential and necessary information for firms in order to encourage GMP compliance. As mentioned in session 3.2, the followings are the granted privileges for GMP-complied firms:
Be allowed to print an additional sentence of “GMP-approved Company” in the label.
Be granted some favors in manufacturing the exports.
Be allowed to cooperate and to be franchised with major well-known pharmaceutical manufacturers in the world for some kinds of products.
Be prioritized in participating in bidding both at national and international level, to supply pharmaceuticals for national health programs.
Be favored in supplying the essential pharmaceuticals for hospitals as well as health programs, which funded by governmental funds or international aids.
Be privileged in approving the production registration, including the pharmaceuticals belonging to the list of limited-granting products.
(Note: the above favors for GMP-complied firms are entirely quoted from the letter No. 284/QLD issued on January 14th, 1998 by the Ministry of Health on favorable conditions for GMP-approved pharmaceutical factories).
The ambiguousness of these favors are analyzed hereunder:
Be allowed to print an additional sentence of “GMP-approved Company” in the label. What does it be...