FDA Thailand What is GMP, and why Thai food and cosmetic plants need it
What is GMP
What is GMP? Good Manufacturing Practice is a set of requirements for a production site's buildings, equipment, process control, sanitation and staff hygiene, so that every batch leaving the plant is consistently safe and of the intended quality, not just the batch that happens to be tested.
Many people think of GMP as an optional certificate that boosts credibility. In Thailand, for food it is a legal requirement: Ministry of Public Health Notification No. 420 B.E. 2563 (2020) requires all food produced for sale to follow GMP, with only a few exceptions. For cosmetics, the Ministry notification on criteria, methods and conditions for manufacturing or importing cosmetics B.E. 2561 (2018) sets premises requirements that manufacturers and contract manufacturers must meet.
This guide explains what Thai food GMP and the cosmetic premises rules require, who must comply and how audits are judged. It is written for companies setting up a plant, brands choosing an OEM partner, and importers.
Thai food GMP requirements: who must follow No. 420
Notification No. 420 replaced nine earlier GMP notifications, including Nos. 193 (2000), 298 (2006), 342 (2012) and 349 (2013), with a single standard. Clause 2 applies it to all food produced for sale, except:
- restaurants and outlets cooking food for immediate consumption, unless they produce specifically controlled food, quality-standard food or label-required food using machinery of 5 horsepower or more in total, or 7 or more workers;
- food stalls in public places;
- salt production sites and fresh produce packing houses already covered by their own notifications.
Note the 5-horsepower or 7-worker threshold. A shop that moves into packaged products with that level of machinery or staff falls under GMP like any factory.
Importers are covered too
Clause 5 requires importers of food for sale to hold documents showing that the foreign manufacturer meets a standard equivalent to or higher than No. 420. Importers therefore need production-system certificates from every source plant.
GMP 420 Thailand: what the standard requires
No. 420 has two parts.
1. Basic requirements (all food plants)
- location and buildings;
- equipment and machinery;
- production process control;
- sanitation;
- personal hygiene.
The numbers to meet under the basic requirements: finished products, including water and ice used as ingredients, must be tested by a government or accredited laboratory at least once a year; records must be kept for at least one year after the expiry date on the label; and the plant must carry out a self-inspection at least once a year.
2. Specific requirements (three additional groups)
- bottled drinking water, natural mineral water and filtered ice;
- pasteurised liquid milk;
- low-acid and acidified foods in hermetically sealed containers.
These producers need a production supervisor trained on a course recognised by the Thai FDA. Low-acid and acidified food plants also need a thermal process authority with a bachelor's degree in food science or a related field who has passed an approved course, and the sterilisation value F0 must be at least 3 minutes.
Thai FDA GMP audit: scoring and major defects
A "Thai FDA GMP" audit usually means the food premises audit under the Thai FDA notification on auditing food premises against No. 420, which uses five record forms:
| Form | Used for |
|---|---|
| Audit report summary | |
| Basic requirements | |
| Drinking water, natural mineral water or ice | |
| Pasteurised ready-to-drink milk | |
| Low-acid and acidified sealed foods |
Scoring and pass criteria
Each basic requirement is scored good 2, fair 1 or needs improvement 0. Items that do not apply are removed from the maximum, and a percentage is calculated per category. To pass, every category must score at least 60% and there must be no major defect. Specific requirements are pass/fail, and every item must pass.
Major defects that fail the audit outright
- no filling room, or no control of post-sterilisation contamination;
- wrong food additive 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 finished products at least once a year;
- for dietary supplements, no production, distribution or recall records.
If nothing is being produced on the audit day, readiness and evidence are assessed, with a follow-up audit later.
Cosmetic GMP Thailand: premises rules under the 2018 notification
For cosmetics, Annex A of the 2018 notification sets requirements for premises, equipment, containers, production methods and storage, for manufacturers and contract manufacturers. Commonly checked points:
- a solid building with floors, walls and ceilings that are easy to clean;
- a permanent sign reading "cosmetic manufacturing site" in Thai;
- at least two separate rooms: production/filling and raw-material/finished-goods storage;
- separation from living quarters, without being a walkway;
- production staff trained or self-studied with written records, and health checks at least once a year;
- process water at least equal to the bottled drinking water standard;
- a master formula matching the notification, records for every batch, batch numbering, quality checks and retained samples of finished goods;
- systems for complaints, adverse reaction reporting and recall.
The premises must be ready before filing, because the notification rules require applicants to have a manufacturing or import site that meets these criteria.
Cosmetic importers: ASEAN Cosmetic GMP and source-plant standards
Annex B of the same notification sets importer obligations. The GMP-related points are:
- import only from plants meeting Annex A or an equivalent standard, such as ISO 22716 or ASEAN Cosmetic GMP;
- hold a letter of authorisation from the brand owner or manufacturer;
- keep the import and storage sites separate from living quarters, with permanent signs for the import site and the storage site;
- keep customs declarations for 5 years, and keep certificates of analysis in the product information file (PIF) for 3 years after expiry or 5 years after manufacture;
- keep product samples at least until expiry.
In practice, request a current copy of the source plant's GMP certificate during contract negotiation, and check that the plant name and address match your other documents. You can screen import documents with the import document checker.
Choosing an OEM partner: GMP questions to ask
A brand that outsources production is not the party being audited, but if the plant fails, the brand's products stop too. Questions to ask before signing:
- Has the site passed an audit under the current criteria, and can you see the evidence?
- Food: is there analysis of finished products and process water at least once a year?
- Cosmetics: is there a master formula, a batch record and a retained sample for every batch?
- Is there a recall and complaints system, and who is responsible?
- For drinking water, pasteurised milk or low-acid canned food, is there a trained production supervisor?
For help setting up a compliant site, see our factory setup and GMP service.
Preparing for a GMP audit
Well-prepared sites usually pass first time. An approach that works for both food and cosmetics:
- Self-assess against the real audit form. For food, use the
ตส.2 items and the product-specific form. No. 420 already requires a self-inspection at least once a year. - Close major defects first, because one is enough to fail regardless of the overall score.
- Complete the documents: analyses, batch records, cleaning records, training records and staff health checks.
- Map the flow of people, materials and products to show there is no cross-contamination point.
To have our team assess your site before quoting a GMP project, contact our team with photos and site details. For staff GMP training, see our training service.
Frequently asked questions
Is GMP mandatory in Thailand?
For food, yes: Notification No. 420 applies to all food produced for sale, with a few exceptions. For cosmetics, manufacturers and contract manufacturers must meet the premises requirements in the 2018 notification.
Does a small bakery need GMP?
Outlets cooking for immediate consumption are exempt, but producing label-required or quality-standard food with 5 horsepower of machinery or 7 workers or more brings a business under GMP.
What score passes a Thai food GMP audit?
Every category of the basic requirements must score at least 60% with no major defect, and every specific requirement must pass.
Must imported cosmetics come from a GMP plant?
Yes. They must come from plants meeting Annex A of the notification or an equivalent standard such as ISO 22716 or ASEAN Cosmetic GMP.
How often must finished food products be analysed under GMP?
At least once a year, by a government or accredited laboratory, including water and ice used as ingredients.
Sources
- MOPH Notification No. 420 B.E. 2563 (2020) on production methods, equipment and food storage · Open source · Search our archive
- Thai FDA notification on auditing food premises against No. 420 · Open source · Search our archive
- MOPH notification on criteria, methods and conditions for manufacturing or importing cosmetics B.E. 2561 (2018) · Open source · Search our archive
- MOPH notification on cosmetic notification, receipts, renewal, amendment and replacement (2018) · Open source · Search our archive
- Cosmetic Act B.E. 2558 (2015) · 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.