FDA Thailand 
Factories / OEM
Applying for a Thai food manufacturing licence: steps, documents and what inspectors check
Who needs a Thai food manufacturing licence, and which laws apply
A Thai food manufacturing licence is the permission a site needs from the Thai Food and Drug Administration (Thai FDA) or the provincial health office before it produces food for sale. Section 14 of the Food Act B.E. 2522 (1979) requires anyone setting up a factory to produce food for sale to obtain a licence first, and section 53 provides imprisonment of up to three years, a fine, or both for operating without one.
Section 16 makes two exceptions: one-off production under a special one-time permit, and production of samples for formula registration or for buyers to evaluate. Both must still follow the ministerial regulations.
Three layers of rules apply directly:
- The Food Act sets the licensing duty, licence validity, relocation and penalties.
- Ministerial Regulation No. 1 (1979) on applying for a licence to set up a food factory sets the forms, evidence and hygiene conditions. Ministerial Regulation No. 12 (2005) amended it so applicants must pass a premises audit first.
- Ministry of Public Health Notification No. 420 (2020), known as GMP 420, is the audit standard and applies to all food produced for sale, with limited exceptions such as restaurants and street stalls.
This guide is for anyone setting up a new site, and for contract manufacturers (OEM) who want to understand the path from first step to licence, and what inspectors look at on site.
Food factory vs non-factory premises
A Thai FDA notice on applying for food manufacturing premises permits (effective 27 October 2019) follows the factory definition in the Factory Act (No. 2) B.E. 2562 (2019): a site using machinery totalling 50 horsepower or more, or 50 or more workers. It splits licensing into two routes:
- Factory scale: file form Or 1 to set up a food factory and receive a food manufacturing licence (Or 2).
- Non-factory scale: file form Sor Bor 1 for a premises number and receive a certificate (Sor Bor 1/1).
An Or 2 is valid until 31 December of the third year after the year it was issued, under section 18. For Sor Bor 1/1, the notice says no renewal is needed, and the Thai FDA food product permit guide says it has no expiry date. Both routes require passing a GMP 420 audit.
How horsepower is counted
The food division’s guide to checking machinery horsepower explains that:
- only machinery used to produce the food being licensed counts, not every machine on site;
- values come from the name plate or catalogue, or are calculated from electrical power, with 1 horsepower equal to 746 watts;
- electric heating equipment such as heaters and sealers is counted at 60% efficiency;
- stoves and boilers have their own conversion methods, and it is sensible to ask the machine seller for horsepower data.
Horsepower and headcount go into the application, so the machinery list should match reality from the start.
Source: Thai FDA notice on applying for food premises permits · Food Act section 18 · guidance under Notification No. 469
Food premises licence application steps
The Thai FDA citizen’s guide to premises audits and the e-Submission manual for new food manufacturing premises (revision 1, 4 September 2026) describe this sequence:
- Create a digital identity: an Open ID with the Digital Government Development Agency, or the ThaID app.
- Request system access: Bangkok sites at the Thai FDA One Stop Service Center; provincial sites at the provincial health office. New sites must first submit the operator appointment and site address so officers can record the base data, which later appears on the audit report and licence, so check it carefully.
- Request a premises audit through e-Submission with floor plans and documents, or use an inspection or certification body registered with the Thai FDA.
- Pass the audit and fix any defects, then receive the audit report.
- File Or 1 or Sor Bor 1, referencing the audit result, entering storage sites, food types and processes, horsepower and headcount, with attachments as signed PDF files. Pay to send the application to officers.
- Answer clarification requests on time; late replies mean automatic return.
- Receive the electronic licence and print it as a PDF from the system.
- Request access again to link your account to the licence number before filing anything else under it, such as food serial numbers.
One point from the manual: storage sites added in the application must be in the same province as the production site. Storage in another province needs its own audit and is added after the licence is issued.
Under section 19, if a licence is refused, the applicant may appeal in writing to the Minister within 30 days of receiving the decision.
- 1Open ID and system accessBangkok at the Thai FDA service centre, provinces at the provincial health office
- 2Request a premises auditVia e-Submission or a Thai FDA-registered inspection body
- 3Pass GMP 420Every category at least 60%, no major defect
- 4File Or 1 or Sor Bor 1Reference the audit, attach signed PDF documents
- 5Receive the electronic licenceThen link your account to the licence number before other filings
Source: Thai FDA e-Submission manual for new food premises · Ministerial Regulation No. 12 (2005)
Food manufacturing licence documents
The Thai FDA checklist for Or 1 and Sor Bor 1 applications and the premises audit guide group the documents as follows.
Operator documents
- Individuals: copies of the operator’s ID card and house registration, and commercial registration.
- Companies: a company certificate issued within six months with food production among its objectives, the shareholder list, and a power of attorney appointing the operator.
- Companies with 50% or more foreign shareholding: a foreign business certificate or Board of Investment (BOI) promotion evidence.
Site and production documents
- An audit report covering the food types applied for, issued within one year or still valid.
- Location map, site plan, and floor plans of every floor to scale.
- Machinery list with horsepower.
- Manufacturing process and flow chart.
- Formula as a percentage by weight, totalling 100%.
- Production volume, water source, cleaning method, waste disposal and number of workers.
- Colour photographs of the building and production line.
Extra documents for higher-risk foods
The guide lists additional documents for groups such as drinking water, natural mineral water, ice, pasteurised milk, low-acid and acidified foods in hermetically sealed containers, aseptic systems, high-pressure processed (HPP) products, dietary supplements, and products containing cannabis or hemp.
Ministerial Regulation No. 1 requires the floor plan to separate areas for raw material storage, production, machinery, packing and finished goods storage, and to show drainage and wastewater handling.
What Thai FDA inspectors check during a premises audit
Audits use GMP 420: five basic requirement categories for every site, plus specific requirements for three groups — bottled drinking water, natural mineral water and ice; liquid pasteurised milk; and low-acid and acidified foods in hermetically sealed containers.
Scoring and the pass mark
The Thai FDA notice on auditing food premises under Notification No. 420 scores each basic item as good (2), fair (1) or needs improvement (0), then calculates a percentage per category. A site passes when every category scores at least 60% and no major defect is found; specific requirements must all pass. If production has not started, the inspector assesses readiness and evidence and follows up later.
Major defects that fail a site outright
- No packing room, or no control of contamination after sterilisation.
- Food additives of the wrong type or amount.
- Water or ice below standard, or no analysis at least once a year.
- No control of the microbial reduction step.
- No analysis of the finished product at least once a year.
- For supplements, no production, distribution or recall records.
What is often checked on the floor
Beyond the GMP forms, Ministerial Regulation No. 1 describes the building: floors and walls easy to clean, production floors sloping to drains, and areas divided as in the floor plan. For the inspection forms Tor Sor 1 to 5, see GMP 420 explained.
Conditions after the licence is issued
Hygiene conditions in Ministerial Regulation No. 1
The regulation sets 14 conditions, for example: use clean water meeting Ministry of Public Health standards; provide enough toilets for the workforce; keep workers with specified diseases out of production; have a doctor examine workers at least once a year and keep the results; and keep animals out of the production area.
Numbers set by GMP 420
- Test the finished product, and water and ice used as ingredients, at a government or accredited laboratory at least once a year.
- Keep records for at least one year after the expiry date on the label.
- Carry out a self-assessment at least once a year.
Duties under the Food Act
- No producing or storing food outside the sites named in the licence (section 20).
- Display the licence and the site sign where they can easily be seen (sections 22 and 23).
- Apply for a replacement within 15 days if the licence is lost or destroyed (section 21).
The licence and serial numbers
The 2024 Thai FDA regulation on food serial numbers says that if an Or 2 or Sor Bor 1/1 is cancelled, every food serial number under it lapses. A contract manufacturer therefore protects every client brand by keeping its licence in order. For the next step, see getting a Thai FDA food serial number.
Renewing a food manufacturing licence, relocating and adding food types
Renewing an Or 2
Section 18 requires renewal to be filed before the licence expires; once filed, the business may continue until the authority refuses renewal. Ministerial Regulation No. 12 requires renewals to pass an audit unless other evidence set by the Thai FDA is provided. A 2022 Thai FDA notice sets two kinds of evidence in place of an audit, either of which is enough:
- a valid food production system certificate whose scope covers the licensed food, from a government body, a government-recognised body or an accredited certification body;
- a passing audit result from Thai FDA officers or a registered inspection body, carried out within the past year.
The Thai FDA notice on renewing food manufacturing licences for 2027–2029 says licences issued in 2024 or renewed in 2023 expire on 31 December 2026, and producers who want to continue must file form Or 3 through e-Submission by that date. If a licence is not renewed before it expires, it cannot be renewed, and all food serial numbers under it lapse. Producing after expiry without filing for renewal carries a daily fine under section 74.
Relocating a production or storage site
Section 20 requires permission before moving. Ministerial Regulation No. 1 uses form Or 5 with the same evidence as a new application, and Ministerial Regulation No. 12 requires an audit as well.
Adding food types
Food division guidance under Notification No. 469 says new food types are added with form Sor 4 for factory-scale sites or Sor Bor 2 for non-factory sites. If floor plans or machinery change, or a food type is added, a premises audit request is needed too.
Preparing the site to pass the first time
Based on the rules and manuals cited here, these steps keep an application moving:
| Area | What to do before filing |
|---|---|
| Site size | List production machinery with horsepower and count workers to choose Or 1 or Sor Bor 1 correctly |
| Floor plan | Divide areas as the regulation requires and show flows of people, materials and products, plus drainage |
| Major defects | Close every one first; a single defect fails the site even with high scores |
| GMP records | Water and product analysis, production records, cleaning records, worker health checks and a recall procedure |
| Base data in the system | Check the operator name and address, which will appear on the licence |
| Storage | Plan storage in the same province, or prepare to add it later |
To have our team assess your site, set up GMP, prepare floor plans and file for you, see our factory setup and GMP service or contact our team. Costs and lead times depend on the site and are given in our quotation. For background, read what is GMP.
Frequently asked questions
Which sites file Or 1 and which file Sor Bor 1?
Sites using machinery totalling 50 horsepower or more, or 50 or more workers, are factories and file Or 1 for an Or 2 licence. Smaller sites file Sor Bor 1 for a Sor Bor 1/1 certificate.
How long is a food manufacturing licence valid?
An Or 2 is valid until 31 December of the third year after issue and must be renewed before it expires. A Sor Bor 1/1 does not need renewal.
Do I pass GMP first or apply for the licence first?
Pass the GMP 420 premises audit first, then file the licence application referencing the audit result.
Can a private inspection body do the audit?
Yes. The manual says the application may reference an audit by Thai FDA or provincial officers, or by an inspection body registered with the Thai FDA.
What happens to serial numbers if the licence lapses?
If renewal is not filed before expiry, the licence cannot be renewed and all food serial numbers under it lapse.
Sources
- Food Act B.E. 2522 (1979) · Open source · Search our archive
- Ministerial Regulation No. 1 B.E. 2522 (1979) on applying for a licence to set up a food factory (unofficial English translation) · Open source · Search our archive
- Ministerial Regulation No. 12 B.E. 2548 (2005) amending the regulation on food factory licences · Open source · Search our archive
- Thai FDA notice on applying for food manufacturing premises permits (2019) · Open source · Search our archive
- MOPH Notification No. 420 B.E. 2563 (2020) on production methods, equipment and storage of food · Open source · Search our archive
- Thai FDA notification on auditing food premises under Notification No. 420 · Open source · Search our archive
- Thai FDA e-Submission manual for new food manufacturing premises · Open source · Search our archive
- Thai FDA checklist for Or 1 and Sor Bor 1 applications · Open source · Search our archive
- Thai FDA citizen’s guide: requesting a premises audit · Open source · Search our archive
- Thai FDA guide to checking machinery horsepower · Open source · Search our archive
- Thai FDA notice on evidence for renewing a food manufacturing licence in place of an audit (2022) · Open source · Search our archive
- Thai FDA notice on renewing food manufacturing licences for 2027–2029 · Open source · Search our archive
- Thai FDA guidance on import and manufacturing premises permits (Notification No. 469) · Open source · Search our archive
- Thai FDA guide to food product permits · Open source · Search our archive
- Thai FDA Regulation on food serial numbers B.E. 2567 (2024) · Open source · Search our archive
This article is for general information. It is not a Thai FDA ruling or legal advice, and rules change — check the latest notification or ask an expert before filing or producing.
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