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Herbal product GMP in Thailand and when PIC/S applies
What herbal product GMP Thailand means and who it covers
Herbal product GMP Thailand refers to the Good Manufacturing Practice rules that every licensed manufacturer of herbal products must follow. They are set out in the Ministry of Public Health (MOPH) Notification on criteria, methods and conditions for manufacturing herbal products B.E. 2564 (2021), issued under the Herbal Products Act B.E. 2562 (2019), and amended twice: No. 2 of 2025 and No. 3 of 2026. The key point is that the rules do not apply one standard to every plant. They split manufacturers by the risk of the production process and by the size of the business.
Under section 4 of the Act, herbal products fall into four groups: herbal medicines (including Thai traditional medicines, medicines developed from herbs, traditional medicines for humans and alternative-medicine remedies), herbal health products, materials used as ingredients in herbal products, and other items named by the Minister. Products that contain herbs but are classed as cosmetics or food are outside this definition, so they follow the manufacturing rules of the cosmetics or food laws instead. If you are unsure which group your product is in, start with Herbal product notification in Thailand: what qualifies.
A factory needs a herbal product manufacturing licence before GMP even comes into play. The Ministerial Regulation of 2020 on licences to manufacture, import or sell herbal products requires a map and coordinates of the site, building plans, qualifications of the responsible person, and documents on wastewater, waste, air-handling and process-water systems. The Act gives the manufacturing licence a five-year life. The licence is the entry ticket; GMP is what the site must keep meeting for as long as it holds that licence.
Thai herbal GMP standard: split by process risk
Clause 3 of the 2021 manufacturing notification defines two risk levels.
- High risk: sterile products, products with modified release of the active substance or a new delivery system, and products using advanced technology or posing high hazard as listed by the Thai FDA.
- Low risk: every other process, such as ordinary tablets, capsules, powders, liquids or general external preparations.
The Thai FDA question-and-answer document from the briefing on Notification No. 3 (30 March 2026) stresses that risk is judged by the production process, not by dosage form. A plain tablet and a modified-release tablet can therefore sit in different groups even though they look alike.
The notification also defines a small manufacturer: a licensee in the One Tambon One Product scheme, a community enterprise, or a business that qualifies as a small enterprise under the SME promotion law. Small manufacturers with low-risk processes have their own criteria.
Several kinds of production at one site
Clauses 7 to 9 say that if a site makes both high-risk and low-risk products, or both finished products and herbal raw materials, the criteria for the higher-risk group apply to the whole site. A factory planning a new line should check first whether that line will pull the entire site up to a stricter standard.
Source: MOPH Notification on herbal product manufacturing (2021), No. 2 (2025) and No. 3 (2026) · Thai FDA guidance on manufacturing standard certification (2026)
Documents 1 to 5: what each set contains
The manufacturing notification attaches its criteria as separate documents, and each manufacturer group uses a different one.
- Document 1 was replaced by Notification No. 3 of 2026. The old version applied the 2016 drug GMP rules by analogy. The Thai FDA guidance on applying for herbal manufacturing standard certification (gazetted 30 April 2026) identifies the new Document 1 as The PIC/S GMP Guide PE-009-16. Part 1 has nine chapters, from the quality system to self-inspection; Part 2 has 20 chapters for active substance manufacture; annexes cover topics such as sterile manufacture, herbal plant manufacture, liquids, creams and ointments, and quality risk management.
- Document 2 covers low-risk herbal products, with ten chapters from quality management to self-inspection. The 2026 Thai FDA guidance calls this set ASEAN GMP.
- Document 3 covers low-risk herbal raw materials. The Thai FDA Q&A notes that ASEAN GMP applies to finished products only; low-risk extracts use the GHPP standard.
- Document 4 is for small manufacturers of oral or internal products. It has definitions and nine chapters: quality management, personnel, premises and equipment, hygiene, documentation, production, quality control, contract manufacture and analysis, and complaints and recalls.
- Document 5 is for small manufacturers of external-use products. A small site making both oral and external products follows Document 4.
Clause 10 of the 2021 notification used to give small low-risk manufacturers a five-year exemption from some chapters of Document 2. Notification No. 2 of 2025 repealed that clause and replaced it with Documents 4 and 5, so small producers still relying on the old exemption should review the new criteria.
PIC/S GMP herbal Thailand: when the upgrade is required
Clause 3 of Notification No. 3 of 2026 names three groups that must follow Document 1 (PIC/S GMP):
- manufacturers of herbal products with high-risk processes;
- manufacturers of herbal raw materials with high-risk processes;
- manufacturers of oral herbal medicines whose annual production value reaches the threshold set in the notification, even if the process itself is low risk.
Choosing to upgrade voluntarily
Low-risk manufacturers, small or not, may choose to apply the high-risk criteria to their site; once they choose, they must comply with Document 1 in full. Under the 2026 Thai FDA guidance, a manufacturer wanting PIC/S GMP files the site inspection request form with supporting documents and a letter of intent under Annex 1. A small low-risk manufacturer wanting ASEAN GMP files the documents in Annex 2.
Existing PIC/S certificate holders
The same guidance said that holders of a PIC/S GMP certificate issued before 25 May 2026 who wished to keep it had to submit documents by 15 June 2026. Those who did not were treated as not wishing to keep PIC/S, and the Thai FDA inspects them against ASEAN GMP instead. The Q&A adds that a site moving from PIC/S to ASEAN must file a label amendment to remove the PIC/S wording.
Common factory questions about PIC/S
- PIC/S GMP does not require a room called a cleanroom or a system called HVAC, but the site must control temperature, humidity, airflow, pressure differentials and air filtration. Pressure values come from a risk assessment, typically about 10–15 pascals between rooms, and a site without a pressure cascade must justify it with scientific evidence.
- The Qualified Person for batch certification should in principle be a responsible person named on the licence.
- Outsourced calibration counts as an outsourced activity that needs a quality or technical agreement under PIC/S Chapter 7.
Thai traditional medicine factory: now under the Herbal Products Act
Many plants still describe themselves as traditional medicine factories, the term used in the Drug Act of 1967. Since the Herbal Products Act took effect, traditional medicines for humans are counted as herbal medicines under section 4, so the manufacturing standard that applies to these plants today is herbal product GMP.
Transitional provisions smooth the change. Sections 124 and 125 of the Act let licences and registrations for drugs or food that are herbal products, issued under the earlier laws, stay valid until they expire. Clause 15 of the 2020 Ministerial Regulation on licences says the same for unexpired licences. At renewal or when applying for a new licence, the plant moves fully into the herbal product system.
Sites making both modern drugs and herbal products
The Thai FDA Q&A says a site producing both modern drugs and herbal products under one licensee and one quality system may ask for a joint inspection by the Drug Control Division and the Herbal Products Division. The assessment cannot be split, so a site cannot seek ASEAN GMP for its oral line alone.
Sharing premises with other product types
Clause 3 of the 2020 Ministerial Regulation allows premises already used to make or store medical devices, cosmetics, drugs or food to be used for herbal products if they meet the required characteristics. This helps a cosmetics plant adding a herbal line, but each line must still follow the rules of its own law.
Site inspection: who inspects and what you receive
The Herbal Products Division guidance on inspecting herbal manufacturing sites (March 2023, issued under the 2021 notification) assigns inspectors by risk.
- High risk, for products and raw materials: inspected by a Herbal Products Division team qualified to the PIC/S inspector standard.
- Low-risk finished products seeking a certificate: apply to the Herbal Products Division; inspection is by Thai FDA officers and/or the Provincial Public Health Office.
- Low-risk herbal raw materials: inspected by Thai FDA inspectors against the criteria attached to the notification.
The guidance adds that low-risk finished products sharing a site with high-risk raw materials must follow PIC/S GMP, and that the scope of any certificate follows the details on the manufacturing licence. Activities not on the licence are not in the certificate's scope.
What a site receives after passing
Under the 2026 Thai FDA guidance, a site that passes against PIC/S receives a PIC/S GMP certificate, and one that passes against ASEAN GMP receives a Certificate of ASEAN GMP. A small low-risk manufacturer that does not seek ASEAN GMP is inspected against Document 4 or 5 and receives a Letter of compliance for Herbal Product Manufacturing Site. If deficiencies are not corrected within the set period, the Thai FDA acts under the law.
Importers using overseas plants
A Thai FDA notification on assessing overseas herbal manufacturing sites lets importers submit documents showing the foreign plant is equivalent to Thai standards. Certificates from PIC/S member authorities go through documentary verification; other standards, such as ISO or supplement GMP, go through a paper assessment of the quality system, and the Thai FDA may require an on-site inspection abroad.
PIC/S GMP and ASEAN GMP marks on the label
A Herbal Products Division announcement (January 2025) allows two marks on herbal product labels or leaflets, PIC/S GMP and ASEAN GMP, under these conditions:
- the applicant holds a herbal product manufacturing licence;
- it holds a GMP certificate covering the same dosage form as the product carrying the mark, and the certificate has not expired;
- the request is filed with a product registration application or a registration amendment, with a copy of the certificate and the undertaking form attached to the announcement;
- the Thai FDA emblem, the words PIC/S GMP or ASEAN GMP and the frame are printed in blue, at any size that keeps the proportions;
- if the certificate is revoked or suspended, labels or leaflets carrying the mark must not be used during that period.
The mark describes the standard of the site and the production process for that dosage form. It does not confirm what the product does, so advertising that presents a GMP mark as proof of product effect should be avoided. Label wording must also follow the herbal product name and label notice; see herbal product notification for the label rules.
Herbal medicine factory GMP Thailand: preparing and choosing a contract manufacturer
For a factory preparing for inspection, a practical order of work is:
- List products and processes for every line, and mark each as high or low risk, finished product or raw material.
- Choose the criteria set by the highest-risk group on site, and decide whether to upgrade to PIC/S voluntarily, taking target markets into account.
- Run a gap assessment of buildings, air handling, water systems and existing documents against the chapters of the chosen document.
- Build documents and records, such as procedures, batch records, quality control records, agreements with outside contractors and a recall system. The Herbal Products Division publishes a sample document set based on basic ASEAN GMP for small manufacturers.
- File the inspection request with current building plans, then correct any deficiencies the inspectors report.
If you would like consultants to look at the premises before filing, contact our team, and read the basics in What is GMP.
Brand owners hiring a factory
The 2020 Ministerial Regulation on registration, detailed notification and notification of herbal products allows a person who hires a licensed manufacturer to file the application. A brand owner therefore does not need its own factory, but should ask to see the factory's GMP certificate, check that its scope covers the dosage form being ordered, and set out contract manufacturing, contract analysis and recall duties in the agreement. If you plan to sell abroad, continue with exporting herbal products from Thailand. For essential-oil products that may be either cosmetics or herbal products, see essential oil classification.
- 1Group the linesHigh or low risk, finished product or raw material
- 2Choose the criteriaFollow the highest-risk group on site, or upgrade to PIC/S
- 3Gap assessmentCompare buildings, air, water and documents with each chapter
- 4Documents and recordsProcedures, batch records, outsourcing agreements and recalls
- 5File for inspectionAttach current plans, then correct the deficiencies reported
Source: MOPH herbal manufacturing notification (2021) and amendments · Herbal Products Division inspection guidance
Frequently asked questions
Does a cream with herbal extracts need herbal product GMP?
It depends on whether the cream is a herbal product or a cosmetic. The Herbal Products Act excludes cosmetics, so a cream notified as a cosmetic follows the cosmetics manufacturing rules. A cream registered or notified as a herbal product must be made at a site with a herbal product manufacturing licence and meet herbal product GMP.
Does a small factory have to adopt PIC/S?
Not if its processes are low risk. A small manufacturer uses Document 4 (oral or internal products) or Document 5 (external products), or may choose ASEAN GMP under Document 2. PIC/S is required for high-risk processes, for oral herbal medicine makers whose production value reaches the threshold, or when a site chooses to upgrade.
Which criteria apply if a site has both high-risk and low-risk lines?
Clauses 7 to 9 of the 2021 manufacturing notification apply the criteria of the higher-risk group to the whole site, including where finished products and raw materials are made at the same site.
Does PIC/S GMP require a cleanroom?
The Thai FDA Q&A says PIC/S GMP does not require the names cleanroom or HVAC, but the site must control temperature, humidity, airflow, pressure differentials and filtration, with values set by risk assessment.
When may a GMP mark appear on a herbal product label?
When the licensed manufacturer holds a valid PIC/S GMP or ASEAN GMP certificate covering that dosage form and applies with a registration application or registration amendment. The mark must be printed in blue in the format set by the Herbal Products Division.
Sources
พระราชบัญญัติ ผลิตภัณฑ์ สมุนไพร พ.ศ.2562 · Open source · Search our archiveกฎกระทรวง การขออนุญาต และการออกใบ อนุญาตผลิต นำเข้า หรือขายผลิตภัณฑ์สมุนไพร พ.ศ. 2563 · Open source · Search our archiveประกาศ กระทรวง สาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไข เกี่ยวกับการผลิต ผลิตภัณฑ์ สมุนไพร ตามพระราชบัญญัติ ผลิตภัณฑ์ สมุนไพร พ.ศ. 2562พ.ศ. 2564 · Open source · Search our archiveประกาศ กระทรวง สาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไข เกี่ยวกับการผลิต ผลิตภัณฑ์ สมุนไพร ตามพระราชบัญญัติ ผลิตภัณฑ์ สมุนไพร พ.ศ. 2562(ฉบับที่ 2)พ.ศ.2568 · Open source · Search our archiveประกาศ กระทรวง สาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไข เกี่ยวกับการผลิต ผลิตภัณฑ์ สมุนไพร ตามพระราชบัญญัติ ผลิตภัณฑ์ สมุนไพร พ.ศ. 2562(ฉบับที่ 3)พ.ศ. 2569 · Open source · Search our archiveประกาศ สำนักงาน คณะกรรมการ อาหาร และยา เรื่อง แนวทาง การขอรับ รองมาตรฐาน การผลิตผลิตภัณฑ์ สมุนไพร ตามประกาศ กระทรวง สาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไข เกี่ยวกับการผลิต ผลิตภัณฑ์ สมุนไพร ตามพระราชบัญญัติ ผลิตภัณฑ์ สมุนไพร พ.ศ. · Open source · Search our archiveประเด็นถามตอบ (Q and A)การประชุม ชี้แจงการบังคับ ใช้ประกาศ กระทรวง สาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไข เกี่ยวกับการผลิต ผลิตภัณฑ์ สมุนไพร ตามพระราชบัญญัติ ผลิตภัณฑ์ สมุนไพร พ.ศ. 2562(ฉบับที่ 3)พ.ศ. 2569 · Open source · Search our archiveประกาศ กองกองผลิตภัณฑ์ สมุนไพร เรื่อง แนวทาง ในการดำเนิน การเกี่ยว กับการตรวจ ประเมิน สถานที่ผลิตผลิตภัณฑ์ สมุนไพร ตามประกาศ กระทรวง สาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไข เกี่ยวกับการผลิต ผลิตภัณฑ์ สมุนไพร ตามพระราชบัญญัติผลิ · Open source · Search our archiveประกาศ สำนักงาน คณะกรรมการ อาหาร และยา เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไข การออกหนังสือ แจ้งผลการพิจารณา มาตรฐาน การผลิตของสถาน ที่ผลิตผลิตภัณฑ์ สมุนไพร ในต่างประเทศ · Open source · Search our archiveประกาศ กองผลิตภัณฑ์ สมุนไพร เรื่อง หลักเกณฑ์ และเงื่อนไข การแสดง เครื่องหมาย การรับรอง มาตรฐาน วิธีการที่ดีในการ ผลิตผลิตภัณฑ์ สมุนไพร บนฉลาก หรือเอกสาร กำกับผลิตภัณฑ์ สมุนไพร · Open source · Search our archiveกฎกระทรวง การขึ้นทะเบียน ตำรับผลิตภัณฑ์ สมุนไพร การแจ้งรายละเอียด และการจดแจ้ง ผลิตภัณฑ์ สมุนไพร พ.ศ. 2563 · Open source · Search our archiveคู่มือการปฏิบัติตามหลักเกณฑ์ วิธีการและเงื่อนไข เกี่ยวกับผลิตภัณฑ์ สมุนไพรตาม แนวทาง การดำเนิน การด้านเอกสาร ตามมาตรฐาน ASEAN GMPขั้นพื้นฐาน (สำหรับ ผู้ผลิตผลิตภัณฑ์ สมุนไพร สำเร็จรูป ที่มีกระบวนการผลิตซึ่งม · 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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