Viet Hung Tran

Institute of Drug Quality Control-Ho Chi Minh City

Received 8 June 2017; accepted 12 September 2017

Email: tran.viethung@nidqc.org.vn

 

Abstract:

The testing capability of the provincial center of drug, cosmetic and food quality control (acronym Quality Control Center, QCC) in Vietnam is overviewed. The main criteria of assessment are based on the standard ISO/IEC 17025:2005 and the WHO GLP. The facilities (infrastructure, equipment), operation expenditure, laboratory management (according to ISO/IEC 17025: International Standard and the WHO Good Laboratory Practices (GLP)), as well as human resources and education,  are analyzed. Currently, 41 of 62 provincial centers have been accredited for achieving the ISO/IEC 17025 standard. These centers are helping to bring international standards into practice in Vietnam, while significantly increasing the efficacy of regulation and quality control of drugs, cosmetics, and foods at the local and national level.

Keywords: Good Laboratory Practice (GLP), ISO/IEC 17025:2005, Quality Control Centers (QCC).

Classification number: 3.3

Introduction

In Vietnam, there are a multitude of state-owned drug quality control establishments including two institutes at the state level (National Institute of Drug Quality Control, Institute of Drug Quality Control - Ho Chi Minh City and National Institute for Food control), 62 Drug Quality Control Centers at the provincial level (except Dak Nong province) and some food control laboratories (belonging to the Preventive Health Center). There is also a military institute of drug and medical equipment quality control and research, belonging to the Ministry of Defense, and associated with the national drug quality system.

According to the Joint Circular No. 51/2015/TTLT-BYT-BNV dated 11 December 2015, issued by the Minister of Health and the Minister of Home Affairs, providing guidelines on the functions, tasks, powers and organizational structure of the Health Department under the People's Committees of provinces and centrally-run cities and the Offices of Health under the People's Committees of districts, towns and provincial cities, it is said that each province and centrally-run city should establish a Food and Cosmetics and Drug Quality Control Center (hereinafter referred to as The Quality Control Center-QCC) [1, 2]. Their functions, tasks and organizational structure are set up and approved by the competent authorities for implementation of control and surveillance of the quality of food, cosmetics, and drugs circulating in the province/city of administration. Almost all the provinces/centrally-run cities have their own QCC. Geographically, the number of QCC is 15 for the Northern Highlands, 10 centers for the Northern Delta and Coast, 14 centers for Central Vietnam, 4 centers for the Central Highlands, 6 centers for the Southeast Vietnam, and 13 centers for the Mekong River Delta. To get an overview of the testing competence of the Drug Quality Control Center system in Vietnam, let us evaluate the following items: facilities, funding, management and human resources.

Facilities

Building

For issuance of an accurate and reliable certificate of analysis, the building should be properly designed with environmental conditions monitored and each analyst should have a work space of at least 30 square meters, in accordance with the current GLP guidelines.

By the end of December 2016, 60 out of 62 QCCs operate independently at their own workplace. However, two QCCs in Binh Phuoc and Hau Giang provinces still share workspace with other organizations. Laboratory size varies significantly among the QCCs. Only 9 of them include a single workspace of over 1000 square meters, those being the centers in Bac Kan, Hanoi, Vinh Phu, Thanh Hoa, Thua Thien - Hue, Gia Lai, Binh Duong, Ho Chi Minh City, and Can Tho. These QCCs are able to design laboratory facilities to suit their functions and operations in accordance with GLP guidelines (each analyst should have a work space of at least 30 square meters) [3, 4].

Equipment

Laboratory equipment is one of the 10 requirements of the GLP. If the QCCs are equipped with enough major equipment, they will be able to actively perform the tests required by the pharmacopoeias such as the US Pharmacopoeia, European Pharmacopoeia, and especially Vietnamese Pharmacopoeia. Equipment is one of the important requirements for assessment of the testing competence of a laboratory in accordance with the GLP guidelines. Many QCCs have been supplied with high precision equipment for application of modern techniques in instrumental analysis such as High-Performance Liquid Chromatographs, Dissolution Testers, NIRs and UV-Vis Spectrophotometers. This equipment helps the QCCs to actively perform almost all the tests required by the pharmacopoeia or the registered in-house specifications. By the end of December 2016, most of the QCCs had been supplied with all necessary basic and advanced equipment. However, the QCCs of the following provinces: Binh Phuoc, Hau Giang, Quang Nam, and Ha Nam are still poorly equipped even with basic equipment. Consequently, tests related to instrumental analysis cannot be fully performed [3, 4].

In addition to major equipment, using funding from various sources, QCCs of the following provinces: Lai Chau, Lao Cai, Quang Ninh, Hanoi, Vinh Phuc, Thanh Hoa, Nghe An, Thua Thien - Hue, Gia Lai, Ho Chi Minh City, Binh Duong, and Can Tho, have procured some sophisticated analytical instruments such as: High Performance Liquid Chromatographs linked to Mass Spectrophotometers (LC/MS), Gas Chromatographs linked to Mass Spectrophotometers (GC/MS), and Atomic Absorption Spectrophotometers (AAS) to enhance the testing competence of their entire QCC systems [3, 4] (Fig. 1).

Fig. 1. (A): High-Performance Liquid Chromatograph, (B) Gas Chromatograph, (C) Dissolution and Disintegration Tester

Funding

According to the data, from 2011 to 2016, government funding granted for QCCs has steadily increased (the total budget for 2016 was twice that of the 2011 budget) [3, 4], reflecting the increased interest in the management of the Health Department via the QCC system. Nevertheless, the funding granted for the QCC system, which is integral to the performing of post marketing surveillance, is small in comparison with the drug spending in total. In 2016, the budget granted for the QCC system was 221.9 billion VND (about 9.6 million USD) which is quite a modest figure in comparison with the turnover of the national pharmaceutical industry (estimated at about 5 billion USD) [5]. And while 32% of the granted budget has been dedicated to quality control testing, the remainder is to be used for staff salaries and other activities of the QCC (Fig. 2).

 

Fig. 2. Graph of the budget granted for the QCC system throughout the years.

The budget granted for the QCC of the system varies from region to region and QCC to QCC. According to the data on the average funding granted per QCC, the QCC located in the Northern Delta and Coast is granted the most funding (3.2 billion VND per QCC) whereas the QCC located in the Mekong River Delta is granted the least (2.4 billion VND per QCC).

In 2016, a budget of over 3.5 billion VND was granted for 23 QCCs, among those the Ho Chi Minh City QCC was granted the most funding (about 12 billion VND). To put this in perspective,  it should be noted that in 2011, there were 7 QCCs (Cao Bang, Bac Ninh, Hung Yen, Phu Yen, Quang Nam, Long An, and An Giang) that were granted only minimal funding (under 1.0 billion VND). This makes it difficult for QCCs to maintain their ordinary activities such as: payment of wages, procurement of solvents and chemicals, procurement and maintenance of equipment, etc. And this allows no funds for extending tests or improving professional qualifications. Fortunately, these QCCs have been shown more consideration in recent years. By 2016, these seven QCCs were granted a budget of over 2 billion VND (3 times higher than that of 2011) - Phu Yen QCC  in particular was granted a hefty sum of over 3 billion VND.

Laboratory management

One of the guidelines for evaluating the testing competence of laboratories is the ISO/IEC 17025 international standard and GLP guidelines [6].

Laboratory management following ISO/IEC 17025

By January of 2017, 41 QCCs have been assessed and found to conform to the requirements of the ISO/IEC 17025: 2005 in the field of chemical and/or biological testing [7]. During the period from 2012 to December 2016, the number of ISO/IEC 17025: 2005 accredited QCCs has greatly increased significantly - by 6 QCCs per year on average. The first QCC that was accredited with compliance with ISO/IEC 17025: 2005 was the Ho Chi Minh City food, cosmetics and drug QCC and the most recent one was the Ba Ria - Vung Tau food, cosmetics and drug QCC, so far. This shows that the testing competence of the QCC system has been increasingly enhanced and the laboratories have been evaluated and accredited by an independent organization.

The entire system has been accredited in pharmaceutical testing. Four centers can perform over 30 tests of accreditation (Ha Noi, Thua Thien - Hue, Can Tho, and Ho Chi Minh City) whereas six of them can perform over 20 tests of accreditation (Vinh Phuc, Thai Binh, Quang Tri, Kom Tum, Vinh Long, and Ha Nam). 10 out of the 37 QCCs have been accredited in cosmetic and food testing and 15 out of 37 have been accredited functional food testing. 7 of 37 QCCs have been accredited in food, cosmetics and drug testing including Lang Son, Phu Tho, Hanoi, Thua Thien - Hue, Gia Lai, Ho Chi Minh City, and Binh Duong.

Laboratory Management Following Good Laboratory Practice Guidelines

GLP (Good Laboratory Practice) [8] represents principles, standards, requirements on organization, and operation of drug quality control laboratories, in order to ensure that it produces accurate and reliable results in drug quality control. By December 2016, 7 QCCs had been accredited with GLP and ISO/IEC 17025: 2005 (Thanh Hoa, Thua Thien Hue, Hanoi, Vinh Phuc, Gia Lai, Quang Tri, and Binh Duong) [3].

Human resources

The workforce of the entire QCC system is comprised of 1,765 persons with 64.6% female staffs [3]. On average, each center has 28 staffs. Notably, Hanoi QCC has the largest number of staffs and Nam Dinh QCC has the smallest.

Working age: staffs of the QCC system belong to the young workforce with the percentage of under-40-year-old staffs at 71.4% of the total staffs in the whole system. The staff group from 31 to 40 years old (41.7%) is a key workforce having both professional qualifications and experience in laboratory management. Under-30-year-old staffs account for 31.7%.

Qualification: the ratio of the university graduate and the postgraduate degree staffs to the entire technician staff body is still low (about 1.6:1). This has not complied with GLP guidelines in terms of staff ratio that should be 3:1. The ratio of university graduate to technician staff is the highest at about 2.9 which approaches the GLP requirement on personnel in the Southeast. The proportion of pharmacist staffs is 54.9% of the total staffs in the whole system. The Northern Delta and Coast has the highest rate of pharmacist staffs (66.7%) whereas the Central Highlands has the lowest rate (37.5%).

General assessment

In general, the testing competence of the QCCs has been significantly improved in recent years. The reason for this positive outcome could be the increase in funding, the spaciousness and modernization of newly built and renovated buildings, and the relative sufficiency of major equipment. Some QCCs have even been investing money in purchasing sophisticated analytical instruments to be able to perform tests on drugs, cosmetics, and food from modern formulated preparation. In addition, over half of the QCCs have been working in the ISO/IEC 17025: 2005 and GLP environment. However, the testing competence may vary from QCC to QCC in various geographical regions. Some QCCs show strong testing competence such as Hanoi and Ho Chi Minh City QCCs whereas some QCCs do not have adequate funding, facilities or human resources. QCCs located in Northern Vietnam have been well funded with good facilities whereas those located in the Mekong River Delta have subpar facilities, in one case, a household was used as a workspace which does not comply with laboratory requirements.

The current QCCs’ basic function is to perform tests for drug and cosmetic quality control. Some QCCs with good resources are assigned to perform tests for food safety in a multi-functional model by the local Health Department.

The Health Department has shown increased interest in the QCC system by continually granting larger budgets and investing financial resources in building infrastructure. However, such investment is still small in comparison with the actual needs for the drug quality control tasks and the total cost for medicines required throughout the country; while the post marketing surveillance task for revealing counterfeit and substandard drugs and ensuring quality of drugs for patients is a very important task in the care and protection of people’s health.

In past years, although there have been many difficulties and technical and economic disparities between geographical regions, the QCCs have steadily overcome obstacles to fulfil their assigned tasks.

In order to improve testing competence to meet the requirements for drug, cosmetics and food according to the Joint Circular No. 51/2015/TTLT-BYT-BNV dated 11 December 2015, the QCCs must establish their organization and operation regulations, and submit them to the relevant authorities for approval. On the basis of this regulation, QCCs can set up projects for the building of facilities, purchasing of equipment, and filling of staff - especially for food analysis. In addition, the QCCs should actively mobilize and efficiently dedicate all resources to the acquisition and management of equipment and human resources; improving testing competence in order to successfully complete the tasks of the drug, cosmetics and food quality control in their regions of administration.

Conclusions

Relevant to Vietnam’s potential entry into the Transpacific Pacific Partnership (TPP), all industries, including the pharmaceutical industry, are facing opportunities and challenges such as: the possibility that foreign medicines will be imported on a larger scale leading to difficulties in their quality control and monitoring; and the effect of this on the local pharmaceutical industry which will have difficulties in competing with foreign companies. In addition, the quality of cosmetics and food is an urgent matter in society. We need to build a technical barrier for control of drugs, cosmetics, and food quality in order to ensure safety for consumers and to serve in the protection, care, and improvement of people's health. According to the functions and task assigned, the Quality Control Centers should focus on the forming and training of quality control staffs, purchasing of analytical equipment, instruments and other devices, and managing of laboratories in accordance with ISO/IEC 17025 and GLP guidelines.

REFERENCES

[1] Minister of Health and the Minister of Home Affairs (2015), Joint Circular No. 51/2015/TTLT-BYT-BNV dated 11 December 2015, providing guidelines on the functions, tasks, powers and organizational structure of the Health Department under the People’s Committees of provinces and centrally-run cities and the Offices of Health under the People's Committees of districts, towns and provincial cities.

[2] Ministry of Heeal, Vietnam (2017), Circular No.26/2017/TTLT-BYT-BNV dated 26 June 2017 by the Minister of Health, providing guidelines on the functions, tasks, powers and organizational structure of the Centers for Disease Control, belongs to  Health Department under the People's Committees of provinces and centrally-run cities and the Offices of Health under the People's Committees of districts, towns and provincial cities.

[3] National Institute of Drug Quality Control (2012), Summary report of Drug Quality Control in years 2011, 2012, 2013, 2014, 2015, 2016 and 2017.

[4] National Institute of Drug Quality Control (2014), Survey the status of the Quality Control Centers in the Provinces/Cities, QCC Competence Investigation and Evaluation, NIDQC Project.

[5] BMI Vietnam Pharmaceuticals and Health care Report Q.4 (2017).

[6] ISO/IEC 17025 international standard and GLP guidelines (2005).

[7] Bureau of Accreditation: boa.gov.vn.

[8] Ministry of health, Vietnam (2000), Good Laboratory Practice guidelines, arcoding to WHO GLP guidelies.