Thai Food and Drug Journal

Editorial

2025-10-30T14:58:09+07:00

Development of Thai Grassroots Entrepreneurs for Sustainable Prosperity through Proactive Value Co-Creation Mechanism: A Case Study of Royal Initiative Projects

2025-10-30T13:11:21+07:00

Background: Promoting the development of health products under the Royal Initiative Projects until they receive approval from the Thai Food and Drug Administration (FDA) helps to enhance the economic value for grassroots entrepreneurs. This was made possible through the collaboration between the Office of the Royal Development Projects Board (ORDPB) and the Thai FDA.

Objectives: To develop and pilot a model for promoting and authorizing health products from the Royal Initiative Projects through a proactive value co-creation mechanism.

Methods: This study employed action research between January and December 2024, consisting of two main phases: Phase 1. Development of a prototype model for promoting and authorizing health products under the Royal Initiative Projects using a proactive value co-creation approach throughout the value chain of health product development. The initial prototype was tested at the Huai Hong Khrai Royal Development Study Center in Chiang Mai Province. Phase 2. Implementation of the prototype in the six additional Royal Initiative Project areas:Khun Mae Kuang Forest Area Development Project, Chiang Mai Province; Omkoi Development Learning Center, Chiang Mai Province; Ao Kung Kraben Study Center for Development, Chanthaburi Province; Khao Hin Son Development Study Center, Chachoengsao Province; Phu Phan Development Study Center, Sakon Nakhon Province; and Pikun Thong Development Study Center, Narathiwat Province.

These trials aimed to assess practical challenges and feasibility of the developed prototype.

Results: The prototype was first tested at the Huai Hong Khrai Royal Development Study Center, where the FDA acted as a co-creator through its regional consumer protection officers. These officers conducted proactive fieldwork alongside the Provincial Consumer Protection and Public Health Pharmacy Group in the Provincial Health Office, Chiang Mai Province to provide guidance to grassroots entrepreneurs throughout the value chain of health product development, resulting in product authorization. The prototype model was then applied to the six additional centers, leading to the authorization of 93 health products in total.

Conclusions: The proactive value co-creation model for promoting health products development under the Royal Initiative Projects has proven effective in guiding entrepreneurs through a systematic and strategic process. It is recommended that this model be adapted and applied to other grassroots entrepreneur groups, such as community enterprises, with contextual modifications being tailored to suit each area.

The Study of the Feasibility of Allowing the Shared Production Facilities for Dietary Supplements and Herbal Products in Thailand

2025-10-30T13:17:54+07:00

Background: The production industry for dietary supplements and herbal products in Thailand faced legal limitations regarding the co-use of manufacturing facilities. This led to increased production costs and a lack of business flexibility, particularly for small and medium-sized enterprises (SMEs) with capital constraints. Current legislation lacks clear guidelines for shared production facilities between food products and other health products, such as cosmetics, herbal products, or traditional medicines, creating uncertainty and restrictions on investment and business expansion. The strict separation of production facilities for each product type results in inefficient resource utilisation and misalignment with modern production trends that prioritise efficiency and cost reduction.

Objectives: This research aimed to define alternative models for the co-use of manufacturing facilities for dietary supplements, as regulated by the Food Act B.E. 2522 (1979), with herbal products in Thailand. It also seeks to evaluate their suitability and feasibility and to investigate regulatory approaches for such facilities to inform the development of post-licensing oversight measures.

Methods: This study was conducted between June 2024 and April 2025, utilising both documentary and qualitative research methods. Documentary research involved a comprehensive review of academic literature, domestic and international legal documents, and relevant regulations. Qualitative research included structured interviews with 11 operators of dietary supplement and herbal product manufacturing facilities who sought consultation on shared facility authorisation at the Thai FDA in July 2024. Additionally, interviews were conducted with three Thai FDA officers experienced in approving manufacturing facility layouts and overseeing post-market regulations for dietary supplements and herbal products.

Results: The study revealed that operators of dietary supplement and herbal product manufacturing facilities believed that shared production facilities for health products are feasible. This was predicated on considering the unique characteristics of each product and applying contamination prevention principles. Four main models were identified: Model 1: a shared production building with clearly separated production areas and distinct entrances/exits; Model 2: a shared production building utilising common conveyor systems but with separate production areas; Model 3: a shared building for storage, manufacturing and packaging but with separate machinery or production equipment; and Model 4: a shared building for storage, manufacturing, and packaging, including shared machinery and production equipment for food and other health products. Interviews with entrepreneurs seeking permission for shared facilities indicated that Models 3 and 4 can be implemented without increasing production costs. However, a risk assessment of the shared facility was essential to determine appropriate cross-contamination control measures. The majority of operators (72.73%) considered Model 4 to be the most suitable due to its potential for reducing costs associated with building construction, machinery, and equipment, as well as ease of maintenance and labour savings. However, Model 4 poses the highest risk of contamination, necessitating rigors risk assessment and the application of Hazard Analysis and Critical Control Points (HACCP) for dietary supplements and Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards for herbal products.

Conclusion: The authorisation of shared production facilities for dietary supplements and herbal products in Thailand was highly feasible both legally and practically, provided stringent and effective control measures are established to maintain product quality and safety. This was particularly crucial for Model 4, where storage, production, packaging areas, and machinery/equipment are shared. Operators must possess the readiness and knowledge to rigorously manage contamination risks. Therefore, clear manuals or guidelines, operator training, and pilot projects are recommended to test the effectiveness of the criteria. Furthermore, supporting the integration of licensing databases and post-licensing monitoring plans between relevant agencies is crucial for effective oversight and building consumer confidence.

The Results of Education to Comply with Good Manufacturing Practice (GMP 420) Regulations and Monitoring of Food Production Facilities in Buriram Province

2025-10-30T13:25:31+07:00

Background: The Thai Food and Drug Administration issued the Ministerial Notification No. 420 (B.E.2563) on production, methods, equipment, and food storage, which was proclaimed in the Government Gazette on February 10, 2021. This notification aimed to update the guidelines regarding food production, equipment, and storage. It took effect for new entrepreneurs on April 11, 2021, onward, and applies to existing food producers with valid food production licenses on October 7, 2021. However, in Buriram Province, it was found that some of the same establishments were still unable to comply; the province promoted educational initiatives for processed food entrepreneurs packaging products in ready-to-sell containers, helping them to meet standards stipulated in the Good Manufacturing Practices (GMP 420).

Objectives: To compare the knowledge and process standards of food production facilities packaged in ready-to-sell containers in Buriram Province.

Methods: This research was a preliminary experimental study that collected data through inspection and recommendation provided to 41 pre-existing food processing facilities that package ready-to-sell food containers in Buriram Province. The study adhered to the Ministry of Public Health Notification No. 420 (B.E. 2563), issued under the Food Act B.E. 2522, between July and December 2022.

Results: The results indicated that the majority of the sample group was 40-49 years old (34.1%), had a high school education or vocational certificate (36.6%), and were business owners (65.9%). The types of food produced were shrimp paste (41.5%), snacks (22.2%), rice (12.2%), sour sausage (4.9%), and others (19.5%). In addition, it was found that 68.3 percent of the sample group knew that food production facilities must comply with the GMP 420 that were enforced by law. An average knowledge score before training was 9.41, and after training, it increased to 14.46 from a 15 score. This post-training average score increased significantly. The overall scores and scores in three GMP 420 categories—(1) Location, Production Building, Cleaning, and Maintenance; (3) Production Process Control; and (5) Personal Hygiene—showed that the average scores after development were significantly higher than before in the food production facilities (p-value < 0.05). Conversely, for two other categories—2) Equipment, Machinery, Production Tools, Cleaning, and Maintenance; and 4) Sanitation—the average scores after development were higher but not statistically different from the pre-development scores (p-value > 0.05).

Conclusions: The research findings show that the provision of educational programs and subsequent monitoring and evaluation of food production facilities significantly contribute to the development of knowledge and standards in accordance with GMP 420 regulation. Consequently, operators have demonstrated a heightened awareness and understanding of regulatory requirements, resulting in improved standards within production facilities. This, in turn, will lead to enhanced quality and safety of food products at both local and international levels.

Situation of Benzoic Acid Usage in Fermented Rice Noodles Sold Across Thai Provinces

2025-10-30T13:44:29+07:00

Background: Benzoic acid is a widely used food preservative that effectively inhibits microbial growth, thereby extending the shelf life of various food products. However, excessive consumption of benzoic acid may pose health risks, including hypersensitivity reactions and metabolic disorders. While regulatory standards exist to limit its use, the levels of benzoic acid in traditional food products, such as Thai rice noodles, remain a public health interest.

Objective: To analyze the levels of benzoic acid in Thai rice noodles sold in Nonthaburi, Nakhon Pathom, Chonburi, and Ubon Ratchathani, categorized by noodle type (fresh and dried) and location of sale.

Method: This research was a cross-sectional study from July 1-31, 2024. A total of 120 Thai rice noodle samples were collected from five provinces in Thailand: Bangkok, Samutprakarn, Nonthaburi, Nakhon Pathom, Chonburi, and Ubon Ratchathani. Samples were categorized by type (fresh or dried) and color. Benzoic acid content was analyzed using a standard detection kit. The results were classified into three categories: low (<1,000 ppm), moderate (1,000 ppm), and high (>1,000 ppm).

Results: Among the 120 samples, 52 (43.33%) contained detectable levels of benzoic acid. Fresh noodles showed a higher prevalence of elevated levels compared to dried noodles. In particular, 49 samples (45.37%) of fresh noodles exceeded the regulatory limit of 1,000 ppm, especially in samples from central Bangkok. Dried noodles generally had lower levels, with only one sample exceeding the standard.

Conclusion: This study demonstrates that some Thai rice noodles, especially fresh varieties sold in urban markets like Bangkok, contain benzoic acid levels exceeding the permitted maximum. Enhanced regulatory monitoring and consumer awareness are recommended to ensure compliance with food safety standards and reduce potential health risks.

Potency Assay Validation for Ranibizumab Using the Vascular Endothelial Growth Factor Inhibition Method

2025-10-30T14:43:33+07:00

Background: Ranibizumab is a monoclonal antibody with a complex structure used to treat ocular diseases caused by abnormalities in the retinal blood vessels. Ensuring its therapeutic efficacy requires rigorous quality control, particularly potency testing. Therefore, developing an accurate and standardized potency assay is essential. The developed and validated potency assay, in accordance with international guidelines, will establish a reliable method for regulatory quality control of ranibizumab in biopharmaceutical laboratories in Thailand.

Objective: To develop and validate a potency assay for ranibizumab using the Vascular Endothelial Growth Factor (VEGF) inhibition method, ensuring its suitability as a standard approach for quality control in support of new drug registration and biosimilar approval in Thailand.

Methods: The experimental study was conducted between October 2022 and September 2023 to develop a relative potency assay for ranibizumab based on VEGF inhibition, with results evaluated against a reference standard. The assay was validated following international guidelines (ICH guideline) by assessing specificity, accuracy, precision, linearity, range, and robustness. The %relative potency was analyzed using geometric mean (GM), geometric standard deviation (GSD), and percent geometric coefficient of variation (%GCV). Statistical differences were assessed using an independent Sample T-test and one-way ANOVA (single factor) to confirm the assay’s reliability and applicability for quality control.

Results: The VEGF inhibition assay demonstrated high specificity and reliability for assessing ranibizumab potency. The relative potency ranged from 80% to 125%, and %Recovery for accuracy was between 100.9% and 104.6%, indicating high accuracy. The %GCV for repeatability and intermediate precision were 6.8% and 6.6%, respectively, both were within the acceptable limits. The assay exhibited appropriate linearity within the 70%–130% range, with a coefficient of determination (R²) of 0.9898. Moreover, variations in HUVEC passage number and cell density did not significantly impact assay performance, confirming its robustness. All validation parameters met the acceptance criteria.

Conclusion: The validation study of the VEGF inhibition assay for ranibizumab potency assessment demonstrates the high reliability and meets international guidelines. The assay can be implemented as a standard method for ranibizumab quality control in regulatory laboratories with high efficiency.

Developing the Potential of Grassroots Food Product Entrepreneurs to Get the FDA Quality Award: Case Study in Surat Thani Province

2025-10-30T14:51:04+07:00

Background: The grassroots economy is crucial for strengthening the local economy, relying on trust in community leaders and government initiatives that support community enterprise projects. Despite the recognition of 10 food product entrepreneurs in Surat Thani province receiving the FDA Quality Award, there remains a lack of a concrete model or practical guidelines. This research therefore aims to develop such a guideline to serve as a prototype for other entrepreneurs.

Objectives: The objectives were to develop a model of grassroots community leader competencies to receive the FDA Quality Award, develop a model for communication and public relations to enhance the marketing competitiveness of community enterprise entrepreneurs, and propose knowledge and a development model for grassroots community enterprise operations towards sustainability.

Methods: This research uses a Research and Development (R&D) method, combining qualitative, quantitative, and participatory action research approaches. The study was conducted in Surat Thani province, with purposive sampling of three groups of participants: a group of 10 community leader entrepreneurs of food products in Surat Thani who have received the FDA Quality Award, to study community leader competency factors; a group of general grassroots food product entrepreneurs who consistently attended meetings with the Surat Thani Provincial Public Health Office (SPPHO), to study media usage behaviour; and a group of 100 academic network members, researchers, lecturers, and food product entrepreneurs, to develop knowledge and a model for community enterprise operations.

Results: The research found that 10 key factors of grassroots community leaders contribute to receiving the FDA Quality Award. These were risk management, creative thinking, communication, self-development, marketing management, product management, social and cultural capital development, network management, financial and accounting management, and personality and integrity. Furthermore, the study on the media usage behaviour of the entrepreneurs found that the duration of the presentation was most important, with an average score of 4.05 out of 5, followed by content appropriateness and consistency, and story sequencing, with an equal average of 4.01. It was also found that the behaviour of consumers in the New Normal era is increasingly shifting towards online shopping. The sample group emphasised the importance of public relations media (average 3.99), expanding to international export markets (average 3.82), and finding new strategies to cope with potential fluctuations (average 3.72). Based on these findings, the researchers proposed four strategic approaches for the sustainable development of the grassroots food business: strategic planning, public participation, sustainable resource management, and evaluation and improvement. A model for developing the potential of grassroots food product entrepreneurs to receive the FDA Quality Award was also simulated in the form of the SURAT Model, consisting of five key components: Standard (S): Product manufacturing standards, Unity (U): Collaborative teamwork and solidarity within the network; Reading (R): Continuous study, research, training, and knowledge exchange; Ability (A): Diverse and well-rounded capabilities; and Technology (T): Keeping up with communication and various media technologies.

Conclusion: This research concludes that the development of grassroots food product entrepreneurs to receive the FDA Quality Award in Surat Thani province requires a combination of various factors, including the 10 leadership competencies and appropriate communication and marketing mechanisms, as well as the application of the four strategic approaches for sustainable business development and the SURAT Model. This will enhance competitive potential and lead to sustainable development.

Bioequivalence Inspection and Corrective and Preventive Actions (CAPA) Part 1

2025-10-30T12:59:21+07:00