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The challenges for implementation of good manufacturing practices by local pharmaceutical manufactures in vietnam
THE CHALLENGES FOR IMPLEMENTATION OF GOOD MANUFACTURING PRACTICES BY LOCAL PHARMACEUTICAL MANUFACTURES IN VIETNAM by Duong To Dung (Ms.) A research report submitted in partial fulfillment of the requirements for the degree of Master of Business Administration Examination Committee Dr Do Ba Khang (Chairman) Dr N Ramachandran Dr Sang-kon Lee Nationality: Vietnamese Previous degree: Bachelor of Chemical Engineering Bachelor of Computer Sciences Engineering Scholarship Donor: HCMC University of Technology Ho Chi Minh City, Vietnam Government of Switzerland Asian Institute of Technology School of Management Bangkok, Thailand March, 2001 i Acknowledgement First of all, I would like to express my deep gratitude to Dr Do Ba Khang, who is my advisor for this research paper, for his kindness and willingness as well as valuable comments and advice that help me well in conducting this paper Moreover, I am also greatly indebted to Dr Cao Minh Quang and Dr Pham Thi Binh Minh, who are chief officers of Vietnam’s Ministry of Health for their whole-hearted supports and helps in giving me the necessary and beneficial knowledge and data concerning Vietnam’s pharmaceutical industry Besides, I truly appreciate the enthusiastic contribution of Dr Sang-kon Lee and Prof N Ramachandran, who are extremely willing to give me helpful advice for improving this research paper Secondly, without the loves and sacrifices of my parents, I could not be here to have a chance of conducting this research Thus, it is my full pride to show my everlasting gratitude to them Thirdly, my acknowledgement is included here to the government of Switzerland, who granted me the scholarship for finishing my MBA at AIT And finally, I would like to send my thanks to all of my teachers as well as friends, who make my life - not only in AIT but everywhere - more valuable and enjoyable ii 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 GMP 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 iii 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 iv GMP List of Abbreviations WHO FDA Good Manufacturing Practices GLP World Health Organization GSP U.S Food and Drug Administration GDP Good Laboratory Practices GPP Good Storage Practices Good Distribution Practices GCP Good Pharmacy Practices SOP Good Prescribing Practices FIP Good Clinical Practices CFR Standard Operating Procedures International Pharmaceutical Federation Code for Federal Regulations v CHAPTER 1 INTRODUCTION 1.1 Background Facing the increasingly fierce competition and rapid globalization trend, companies around the world have to ensure their products’ quality by complying with some types of quality assurance standards or regulations, which are internationally or globally recognized In pharmaceutical, food, cosmetic, and some other industries, the Good Manufacturing Practices (GMP) regulations are mostly used What is GMP? In pharmaceutical industry, GMP is a quality assurance system for ensuring that products are consistently produced and controlled according to quality standards, and it is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product Those main risks are: - Unexpected contamination of product, causing damage to health or even death - Incorrect labels on containers, which could mean that patients receive the wrong medicines - Insufficient or too much active ingredients, resulting in ineffective treatment or adverse effects GMP covers all aspects of production, from starting materials, premises and equipment, to the training and personal hygiene of staff Detailed, written procedures are essential for each process that could affect the quality of the finished product Furthermore, there must be systems to provide documented proofs that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made The figure hereunder illustrates the ten major components of GMP General Production Personnel Quality control Premises Self-inspection Equipment Handling of complaint and recall Sanitation Documentation Figure 1.1: Ten major contents of GMP 1 Why GMP? Two levels are mentioned hereunder as the reasons for implementing GMP standards: the macro level relating to the national policies and benefits, while the micro level concerns the firm’s benefits - Macro level: Economic aspects: + Most countries will only accept import and sales of medicine that have been manufactured to internationally recognized GMP + Governments seeking to promote their countries’ export of pharmaceuticals can do so by making GMP mandating for all pharmaceutical production Social and humane aspects: + Implementation of GMP is an investment in good quality medicine, that helps improve the health of individual patients as well as the community in terms of patient safety, recovery times and the like - Micro level (firm-level): + Making poor quality products does not reduce costs In the long run, it is more expensive in finding mistakes after they have been made than preventing them in the first place and first time GMP is designed to ensure that mistakes do not occur, thus, helps firms reduce production costs significantly in the long term + Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care as well as the manufacturers GMP helps firms build their credibility through producing quality products In Asian region, many countries have not enforced the GMP compliance of pharmaceutical manufacturers while merely encourage them to implement the GMP guidelines for their own competitive advantages Moreover, there is not a mutual recognition for national GMP guidelines and regulations among members of ASEAN, which is a considering obstacle to the pharmaceutical market opening process in the region In Vietnam, the Drug Administration formed in August 1997 is responsible for establishing the GMP guidelines and granting the GMP - compliance certificates However, these certificates are effective only in Vietnam, as they are not recognized in other countries From 30 October to 1 November, 2000, there is a meeting of ASEAN members in Hanoi – Vietnam, relating to pharmaceutical issues, includes a discussion of approaches to the mutual recognition of ASEAN GMP certificates in the region However, this issue is out of this research’s scope, hence, it is not mentioned in detail herein 2 1.2 Problem Statement As aforementioned, the ongoing challenges faced by Vietnam’s Ministry of Health are: How to establish or amend GMP guidelines and regulations, which are both appropriate to the domestic conditions and agreed with ASEAN GMP guidelines, that will become the regulations in the near future What can the government do to promote pharmaceutical firms’ GMP compliance What can the government do to support and reinforce the domestic pharmaceutical firms’ capabilities in order to sustain and develop in the on-going boundless market 1.3 Objectives In this research paper, the following objectives are supposed to be attained: To review the general concepts of quality assurance as well as ASEAN GMP guidelines for pharmaceutical industry To compare GMP standards and ISO 9000 series of standards To present a broad view of the current situation of Vietnamese pharmaceutical industry and GMP compliance of pharmaceutical companies in Vietnam To outline pharmaceutical manufacturers’ difficulties and constraints relating to the GMP compliance in Vietnam Based on external benchmarking and internal auditing, to propose recommendations to: - Firms for overcoming the challenges and successfully implementing GMP - Government for promoting pharmaceutical firms’ GMP compliance 1.4 Scope of study This research paper focuses only on the GMP guidelines and regulations for pharmaceutical industry in general, as well as the GMP implementation situations in Vietnam, which concentrated on finding out both internal and external challenges faced by firms in the process of obtaining GMP conformity 3 1.5 Methodology This research is conducted based on three critical tasks: Theoretically reviewing the quality assurance in pharmaceutical industry in general, Data collecting about Vietnamese pharmaceutical manufacturers in terms of revenues, GMP compliance, labor forces, capitals as well as the Vietnamese government’s policies towards firms’ GMP conformity, and Finally, basing on the collected information, recommendations are made to firms, government (Ministry of Health) and further studies The research methodology framework is presented in the following diagram: Describe general concepts of Quality Theoretical Assurance in Pharmaceutical Industry Review From Internet, books, journals Review ASEAN GMP From Internet, books, journals Compare GMP vs ISO From Internet, books, journals Review and describe the Actualities of current situations of pharmaceutica l industry and pharmaceutical industry in Vietnam, focusing on GMP GMP Implementatio compliance n in Vietnam From secondary data, available at the Recommen- Drug Administration of Vietnam -dations Find out challenges faced by For firms, for government, and firms in implementing GMP for further studies Personal interviews 4 Figure 1.2: Research framework of this paper 1.6 Overview The entire research paper is divided into four chapters as the following: Chapter 1: presents a general overview of the background information, current problems, objectives and scope of the research study as well as the methodology for conducting this research paper Chapter 2: discusses briefly the quality assurance concept in pharmaceutical industry and ASEAN GMP guidelines A comparison of GMP versus ISO 9000 series standards is included as well Last but not least, some pros and cons of quality standards are also considered Chapter 3: outlines the actualities of pharmaceutical industry in Vietnam in terms of market structure and governmental policies Moreover, the GMP compliance in Vietnam, as well as governmental policies relating to GMP implementation is also included Aside from those, the internal and external challenges faced by firms in implementing GMP are also presented Chapter 4: presents the recommendations to firms for overcoming the challenges and better practicing in implementing GMP standards Also the recommendations to government for speeding up the GMP compliance of pharmaceutical manufacturers are addressed 5 ... obstacle to the pharmaceutical market opening process in the region In Vietnam, the Drug Administration formed in August 1997 is responsible for establishing the GMP guidelines and granting the GMP... well that the quality assurance of clinical therapy (including Good Clinical Practices and Good Prescribing Practices) is not less important than the 5g-P principle in quality assurance of pharmaceutical. .. became official and were enforceable by law in March 1979 These regulations present the minimum requirements to be met by pharmaceutical industry for the manufacturing, processing, packaging,