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Navigating the New Landscape: Thailand’s Government Regulations for Medical Cannabis – GACP Guidelines (English Translation) 

October 25, 2023 | Category : Cannabis Compliance Country Reports Cannavigia | Posted By : Team Cannavigia

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In a rapidly evolving global landscape, the acceptance and regulation of medical cannabis have become a focal point for nations aiming to harness its therapeutic and economic potential. Leading the charge in Asia is Thailand, whose progressive stance has marked a significant stride with the recent publication of the Good Agricultural and Collection Practices (GACP) guidelines by the Thai Ministry of Public Health. As you explore the regulatory strides Thailand is making, a deeper understanding can be attained by delving into our comprehensive Cannabis Compliance Report on Thailand, which sheds light on the pivotal steps taken by the nation in embracing medical cannabis.

The GACP guidelines are crucial for ensuring consistent quality and safety from cultivation to processing of (medicinal) cannabis. They encompass a set of principles aimed at minimizing risks throughout the production process, covering aspects like personnel training, documentation, and quality control. This regulatory framework not only shows a proactive approach to ensuring the highest standards in cannabis cultivation and processing but also narrates a part of the extensive History of Cannabis in Thailand, tracing the evolution of cannabis culture and its legal status in the region.

Table of Contents:

  1. Quality Assurance
  2. Personal Hygiene
  3. Documentation
  4. Equipment
  5. Site
  6. Water Supply
  7. Fertiliser
  8. Seed and Propagation Material
  9. Cultivation
  10. Harvesting
  11. Primary Processing
  12. Building
  13. Packaging and Labelling
  14. Storage and Distribution

 

The release of the GACP guidelines underscores Thailand’s earnest commitment to establishing a robust regulatory framework for its burgeoning cannabis sector. At Cannavigia, we’ve translated these pivotal guidelines into English, aiming to bridge the information gap and provide stakeholders, as well as cannabis enthusiasts worldwide, a comprehensive understanding of Thailand’s evolving medical cannabis regulatory framework.

Dive into our latest blog post to explore the translated GACP guidelines and delve into the ambit of Thailand’s regulatory vision in the medical cannabis sector. Your gateway to understanding Thailand’s medical cannabis regulations unfolds here:

Specifications   
1. Quality assurance    
1.1 Control every step of production to ensure product quality and safety. Comply with partner requirements.    
2. Personal Hygiene    
2.1 Operators must have knowledge about the botanical characteristics of the cannabis plant. Factors of production: planting, harvesting, processing, and storing raw materials of cannabis herbs.    
2.2 Post-harvest and processing workers/staff should have sufficient knowledge of their operations to avoid deterioration of the quality of the cannabis raw materials.    
2.4 Workers/Staff must wash their hands when starting work after entering the restroom or touching any hazardous materials.    
2.5 It is forbidden to smoke and eat in the working area and they are not allowed to engage in any behaviour that affects the pollution and corrosion quality of cannabis raw materials.    
2.6 Attention should be paid to employee welfare, necessary facilities should be provided and annual health checks should be conducted.    
2.7 Workers/Staff must comply with labor laws.    
2.8 Workers/Staff must have sufficient protective devices to prevent potential hazards caused by contact with any substance that may cause irritation or allergy in the process of producing cannabis raw materials.    
2.9 Workers/Staff who use organic substances, biological products and fertilizers must receive training and wear appropriate protective clothing.    
2.10 Workers/Staff who are sick or suspected to be sick are not allowed to work.    
2.11 Workers/Staff with wounds and various skin injuries should be suspended from work or wear protective clothing to prevent contamination of cannabis products or cannabis raw materials.    
2.12 Third parties entering the cannabis plant production area must comply with the manufacturer’s hygiene rules and regulations.    
3. Documentation    
3.1 There has to be an operating manual (standard operating procedure or SOP) for every step related to production, harvest, and preliminary processing to maintain the quality of cannabis raw materials.    
3.2 The history of the land that the crop is grown on should be documented in a retrospective manner, while pest outbreaks are monitored for a minimum of two years.    
3.3 Activities at each production step must be documented, including the tasks performed, the date of completion and the worker’s name, all in accordance with the work manual.    
3.4 There must be a record of the list of production factors, their sources, and specific details of the production factors    
3.5 The environmental factors that impact the quality and safety of cannabis raw materials must be documented.    
3.6 Information regarding the utilisation of organic and biological substances within the planting plot must be recorded on each occasion, including details such as the type of substance, the purpose of its use, the date of application, the rate and method of application and the name of the worker responsible for the application.    
3.7 Cannabis raw materials that are undergoing storage, transportation and packaging for sale must be clearly labeled with the product version (batch) and attached with a code or mark that indicates the origin of production and the harvest date. This ensures the ability to trace the product back to its source.    
3.8 Store every document created between producers, processors, buyers and distributors    
3.9 Keep records of the results of both internal and external audits, including all complaints from business partners    
3.10 Conduct a review of operations, records, and complaints at least once a year to ensure production processes and improve work procedures to meet objectives, including keeping records of reviews and corrections as evidence.    
3.11 Records, complaints and corrections must be kept as evidence for at least 2 years.    
4. Equipment    
4.1 Equipment, containers and materials that come into direct contact with cannabis plants must be maintained in a clean and sanitary condition to prevent any potential contamination.    
4.2 All tools and equipment used in the production of cannabis raw materials must be resistant to corrosion, easy to clean and should not be fabricated from materials that introduce toxicity or alter the aroma, taste, and other vital characteristics of the cannabis raw materials.    
4.3 All tools and equipment should be designed and constructed with safety to prevent harm to the operator. They should also be designed to minimise the risk of contamination to cannabis plants, easy to clean and inspect, to ensure their continued safe and efficient operation.    
4.4 Regularly inspect agricultural tools and equipment that require precision in operation. If any discrepancies or issues are detected, they must be promptly addressed through repair or replacement to ensure that they meet the standard performance requirements when used. These inspections should be conducted at least once a year to maintain optimal functionality and safety.    
4.5 Waste containers should be equipped with waterproofing and easy cleaning. They should have tightly closing lids to contain waste securely.    
4.6 Trashcans used for waste disposal must be clearly labeled to distinguish them from containers used in the production process and waste should be disposed every day.    
5. Site    
5.1 Planting areas and materials used for cultivating must be maintained to prevent contamination from heavy metals, chemical residues, disease-causing microorganisms and any other contaminants that could compromise the safety of cannabis herbal raw materials.    
5.2 Collect soil samples and cannabis plant material (substrate) for analysis of toxic residues and heavy metals before planting. This should be done at least once before each planting cycle.    
6. Water supply  
6.1 Collecting water samples for analysis of toxic residues and heavy metals before growing cannabis plants. It should be done at least once before initiating the planting process.    
6.2 Have an irrigation method that is appropriate for the environment and the needs of cannabis plants    
6.3 Wastewater that has been treated for use in the cannabis plant production process is not permitted.    
7. Fertiliser    
7.1 Use fertilisers that are legally registered.    
7.2 Fertilisers should be used according to the needs of cannabis plants and of the nature that does not cause any impact on the environment    
7.3 Fertiliser use should be well-managed to prevent contamination by non-pathogenic microorganisms, chemicals and physical factors that could compromise the safety and quality of cannabis herbal raw materials.    
7.4 Human excretion should not be used as a source of fertiliser    
7.5 When farmers produce organic fertiliser for use on their farms, it is essential that the organic fertiliser undergoes a complete composting or decomposition process. Additionally, they should maintain records of the source of raw materials and production methods for transparency and accountability.    
7.6 The area designated for storing, mixing, and transporting fertiliser or for composting organic fertiliser must be separate from growing areas and water sources to prevent contamination.    
8. Seed and propagation material    
8.1 Cannabis seeds and propagation materials must be of high quality, free from pests, according to the specified species as per the requirements.    
8.2 Should be able to verify the origin of cannabis seeds and cannabis plant propagation.    
8.3 There are measures in place to prevent the mixing or adulteration of different types and strains of cannabis plants during the production process.      
9. Cultivation    
9.1 Production control measures should be implemented at each step to ensure that they do not compromise the safety of product quality, the environment or the health and safety of the producer, consumers and local communities.    
9.2 The production of cannabis plants should be mainly based on ecological agriculture which is beneficial to the communities and society in neighbring areas.    
9.3 Use an appropriate integrated pest management system (Integrate Pest Management; IPM) and do not use chemicals to prevent and eliminate pests.    
9.4 When using organic substances or beneficial plant growth promoters, they should be used at an appropriate level and minimise the impact on cannabis plants.    
9.5 Only organic or biological substances are permitted for use in pest prevention and elimination, in compliance with the law.    
9.6 The use or possession of agricultural hazardous substances that are prohibited from being produced, imported, exported, or possessed under the Hazardous Substances Act B.E. 2535 and its amendments is strictly prohibited, except for organic or biological substances, which are allow E.g. such as explosives, flammable materials,oisonous materials, radioactive materials and etc.  
9.7 Chemical sprayers and equipment, including correct chemical spraying methods, should be effective and consistent.   
9.8 Clean the sprayer and equipment after each use and remove the wash water in a way that does not pollute the environment.    
9.9 Store all kinds of organic substances or biological substances in a specific storage place to prevent the pollution of individual substances. Make sure the extraction does not pollute or cause harm to people.    
10. Harvesting    
10.1 Cannabis plants should have appropriate harvest periods to ensure the best quality of cannabis medicinal raw materials.    
10.2 Harvesting should be carried out in a suitable climate range and harvesting in the open air, rain, or high humidity should be avoided.    
10.3 Unsuitable cannabis medicinal raw materials shall be inspected and disposed during the post-harvest period to prevent the generation of fungi and the quality loss of cannabis raw materials.    
10.4 During the harvesting process it is strictly prohibited to mix weed impurities and toxic plants with cannabis medicinal raw materials.    
10.5 Prevent harmful objects from contaminating products collected on land plots. Do not place the harvested crops directly on the ground.    
10.6 Cannabis raw materials shall not overlap to avoid damaging the cannabis after harvest.    
10.7 Keep the equipment and instruments clean to reduce damage and pollution and maintain the quality of cannabis medicinal raw materials.    
10.8 During the harvesting process, practitioners must maintain cleanliness and operational readiness to minimise damage and pollution and uphold the quality of cannabis herbal raw materials.    
10.9 The containers of cannabis raw materials must be clean and free from other impurities and the previous cannabis raw materials shall be collected from the waste materials.    
10.10 Preventive measures must be implemented to ensure that animals and livestock are not exposed to contamination from harvested cannabis products.    
10.11 Transport harvested cannabis carefully to the designated collection point, taking precautions to prevent any increase in moisture levels in the raw materials during transportation.    
10.12 During transportation, it is crucial to implement measures that prevent the raw materials from being contaminated, tampered with or adulterated by heavy metals, chemical residues, pathogenic microorganisms or other fraudulent products that could jeopardize the safety and integrity of the cannabis raw materials.      
11. Primary processing    
11.1 After the raw materials are harvested, when the cannabis reaches the processing site, the light-proof and moisture-proof container should be quickly removed and stored in an appropriate place to avoid the deterioration of the raw materials due to high temperature and prevent the formation of microorganisms.    
11.2 If the raw materials are processed into dry cannabis after harvesting, they should be dried in an appropriate place. Prevent the deterioration of dry cannabis materials due to high temperature and prevent the occurrence of microorganisms.    
11.3 Processed raw material should be stored in a place where the temperature and humidity are properly controlled to minimise damage.    
11.4 There are measures to reduce the humidity of cannabis herbal raw materials that can prevent quality loss and effectively prevent contamination.    
11.5 The medicinal cannabis raw materials harvested from the plot must undergo a screening and inspection process.    
11.6 In the preliminary processing stage of herbal medicine, the raw material must be o inspected to eliminate unqualified raw materials and fake and shoddy products.    
11.7 The raw material harvested from the plot must be properly cleaned to make them suitable for the production process.    
11.8 The appropriate measures for the primary processing of raw materials must meet the requirements of national, regional and partner standards.    
11.9 In all steps of preliminary processing, measures must be taken to prevent pollution and decay and no interference from animals must be found.   
11.10 The use of processing methods that may affect safety must be noted and explained, such as irradiation methods. This practice must be carried out by officials with expertise in this field and must meet the requirements of the country of origin and trading partners.      
12. Building    
12.1 The location of the preliminary processing building shall not have odour, smoke, fire, dust or pollutants, nor shall it be a place of flooding.    
12.2 The building for preliminary treatment, must be solid, clean and convenient. It should prevent sun, external pollution and animals. Temperature and humidity should be controlled and it should be well ventilated.    
12.3 Materials used for building shall not be cross-contaminated with raw materials of cannabis herb.   
12.4 The internal structure and components of the primary medicinal processing zone should be made of durable, easy-to-maintain, clean and easy-to-disinfect materials and made of non-toxic materials which will not react with the medicinal raw materials of cannabis and will not cause cross-contamination.    
12.5 Isolate areas with different levels of hygiene control to prevent cross-contamination    
12.6 Provide disinfection equipment and equipment required for proper cleaning and disinfection.    
12.7 The sink and changing room must be sufficiently hygienic and equipped with the necessary equipment.    
12.8 Water must be clean, have proper water quality adjustment suitable for the initial treatment process, have sufficient water collection and water supply equipment and must be able to prevent pollution.    
12.9 The sewage system must be efficient and not affect the environment, to prevent contamination with water used in the planting plots    
12.10 The lighting in the operating place must be sufficient and the light bulbs in the roof must be protected to ensure that it will not pollute the raw materials if it is broken or damaged.    
13. Packaging and labelling    
13.1 The preliminary processing of raw materials should be properly packaged as soon as possible to prevent the deterioration of light, temperature, humidity and pollution.    
13.2 During the period from processing to packaging, the quality of raw materials shall be continuously monitored.    
13.3 Tools, equipment, and containers for processed raw materials should be appropriate. It should be undamaged, clean and dry without reactions that cause changes to the quality of the raw materials. It should be consistent with what is specified in Standard Operation Procedures.    
13.4 Reusable containers must be clean and must not cause pollution or contamination.     
13.5 Containers should be stored in a clean and dry place, free from carriers, pests and sources of pollution.    
13.6 The label on the container must be clear, indicating the scientific name, plant parts, source, manufacturer’s name, production model, harvest date, production date, quantity and other information, so as to meet the requirements of partners and partner countries.    
14. Storage and distribution    
14.1 Equipment for transporting packed raw materials must be clean and protect from light, temperature, humidity, and contamination.    
14.2 The medicinal cannabis raw materials packaged must be stored in dry and well-ventilated conditions.    
14.3 The room for storing raw materials must be clean and have measures to control light, temperature, and humidity and prevent contamination.   

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