Factories / OEM

What is ISO 22716? Cosmetic GMP explained for Thai factories and importers

10 min read · Updated 14 Nov 2026

What is ISO 22716: the international guideline for cosmetic GMP

ISO 22716 is a term that cosmetic brand owners, importers and contract manufacturers in Thailand meet more and more often: in documents from overseas suppliers, in quotations from OEM factories, and in the document lists that foreign buyers send. The questions that follow are always similar. What exactly is ISO 22716, how does it differ from the GMP that the Thai FDA inspects, and if a factory already holds this certificate, what else still needs to be done?

The short answer: ISO 22716 is an international standard that gives guidance on Good Manufacturing Practices (GMP) for cosmetics. It is published by the International Organization for Standardization (ISO). The edition referred to in practice is ISO 22716:2007, whose full title is Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices.

The core of ISO 22716 is not the formula or the performance of the product. It is about making every batch come out the same, clean, traceable and backed by written records, from the receipt of raw materials through production, packaging, quality control and storage, up to the shipment of finished products from the factory. Worker safety, environmental protection, research and development of formulas, and distribution after the goods leave the factory are outside the scope of the standard.

One more point to understand from the start: ISO does not issue certificates itself. ISO 22716 certificates seen on the market are issued by third-party certification bodies that audit the factory against the standard. How much a certificate is worth therefore depends on who issued it, which is covered in the section on checking certificates below.

If GMP in general is new to you, start with What is GMP, which compares GMP for food, cosmetics and herbal products in one place.

What ISO 22716 covers: 15 areas a factory must organise

The body of ISO 22716 runs from clause 1 to clause 17. Clause 1 sets the scope and clause 2 gives definitions; clauses 3 to 17 are the 15 areas a factory actually has to put into practice. In practical terms they mean the following.

• Personnel: an organisation chart, clear responsibilities, and trained staff with training records.
• Premises: areas separated by use, easy to clean, protected against contamination and pests.
• Equipment: designed to be cleaned, measuring devices calibrated, a maintenance plan in place.
• Raw materials and packaging materials: bought to specification, inspected on receipt, held in quarantine until released, with a clear status label.
• Production: made to an approved master formula and procedures, with a batch record for every batch.
• Finished products: released only when they meet the acceptance criteria, then stored and shipped under control.
• Quality control laboratory: test methods, acceptance criteria and retained samples.
• Out-of-specification product: a procedure to investigate and decide whether to reprocess, rework or destroy.
• Waste: handled so that it cannot come back and contaminate production.
• Subcontracting: a written contract and control over contract manufacturers and contract laboratories.
• Deviations: any departure from a procedure is recorded with its justification and approval.
• Complaints and recalls: complaints are received and investigated, and products can actually be recalled.
• Change control: changes to formulas, equipment or suppliers are assessed and approved beforehand.
• Internal audit: the factory audits its own system regularly and corrects what it finds.
• Documentation: documents are written, approved, distributed and archived systematically.

ISO 22716 is written as a guideline. It mostly says what should be achieved rather than prescribing room sizes or machine brands. Each factory therefore has to design its own methods and prove through records that they work. Auditors look both at the written procedures and at evidence that people really follow them.

Cosmetic GMP in Thailand: the legal minimum and voluntary certification

In Thailand, cosmetic GMP is discussed at two levels that are often mixed up: the legal minimum that every manufacturer must meet, and voluntary certification.

Level 1: premises requirements under the 2018 notification

The Ministry of Public Health notification on criteria, methods and conditions for manufacturing or importing cosmetics B.E. 2561 (2018), issued under the Cosmetic Act B.E. 2558 (2015), requires manufacturers for sale and contract manufacturers to comply with Annex A, while importers for sale comply with Annex B. Examples of Annex A requirements include:

• at least two separate rooms: one for production and filling, one for storing raw materials, packaging and products;
• separation from living quarters, and the production area must not be a passageway to other areas;
• a permanent sign reading "cosmetic manufacturing site";
• staff who know good manufacturing practice and hygiene, with training records;
• equipment made of materials that do not react with the product or contaminate it;
• records for production, quality control, complaints and recalls.

A manufacturing site must pass an inspection against these criteria before it can be used for cosmetic notification. The Thai FDA publishes an inspection guide for this notification that businesses can use to prepare. The whole notification process is explained in How to notify cosmetics in Thailand.

Level 2: ASEAN Cosmetic GMP certification from the Thai FDA

A manufacturer that wants to show its system goes beyond the minimum can apply for certification against the ASEAN Guidelines for Cosmetic Good Manufacturing Practice. The rules are set out in the Thai FDA regulation on cosmetic GMP certification (document RL-CH4-1, revision 2, effective 9 December 2025). The key points are:

• the applicant must be a notification holder that manufactures or contract-manufactures cosmetics;
• the GMP requirements must be implemented across the whole system before applying, with at least three production batches of notified products, internal quality audits and a management review;
• audits are carried out by a Thai FDA team or by an inspection body named by the Thai FDA, whose list is published on the cosmetics division website;
• major and minor defects must all be corrected, while a critical defect means the site fails and must be audited again.

In short, Level 1 is what every manufacturer must do. ASEAN Cosmetic GMP and ISO 22716 are higher standards that a factory chooses to pursue for credibility, to serve brand customers, or to export.

ISO 22716 vs ASEAN Cosmetic GMP

Both standards aim at the same outcome: every batch of cosmetics should be safe and of consistent quality. Their content therefore overlaps heavily, covering personnel, premises, equipment, production, quality control, documentation, internal audit, complaints and recalls. The differences lie mainly in who certifies and which markets recognise each one.

• Author: ASEAN Cosmetic GMP is an appendix to the ASEAN Harmonized Cosmetic Regulatory Scheme; ISO 22716 is published by ISO.
• Who certifies in Thailand: ASEAN Cosmetic GMP certificates are issued by the Thai FDA after an audit by the Thai FDA or an inspection body; ISO 22716 certificates are issued by private certification bodies.
• Familiar markets: ASEAN Cosmetic GMP is well known within ASEAN member states. ISO 22716 is recognised more widely around the world, and the European Union uses it as the reference standard for showing GMP compliance under the Cosmetics Regulation (EC) No 1223/2009.
• Level of detail: ISO 22716 has separate clauses for out-of-specification product, deviations, change control and waste; ASEAN Cosmetic GMP has separate chapters for sanitation and hygiene and for storage.

In practice, a factory whose system is good enough to pass one standard can usually extend it to pass the other without much difficulty, because most documents and records are shared. The useful question is which certificate your customers or destination markets ask for.

ISO 9001, by contrast, is a general quality management system, not cosmetic GMP. The ASEAN question-and-answer document on interpreting the cosmetic GMP guideline says an ISO 9001 quality manual is acceptable only if it covers all GMP elements. An ISO 9001 certificate alone therefore does not show that a factory follows cosmetic GMP.

Importers: is a foreign manufacturer's ISO 22716 certificate accepted?

Yes. Clause 4.1.1 of Annex B of the 2018 notification requires importers for sale to import cosmetics made by manufacturers certified against Annex A or against an equivalent or higher manufacturing standard. It lists seven accepted standards:

1. WHO Good Manufacturing Practices (GMP) for pharmaceutical products
2. Pharmaceutical Inspection Co-operation Scheme (PIC/S)
3. Australian Good Manufacturing Practices (GMP) for pharmaceutical products
4. ISO 22716 Cosmetics Good Manufacturing Practices (GMP)
5. CTFA Guideline for Cosmetic Good Manufacturing Practices (United States)
6. Cosmetic Good Manufacturing Practices of COLIPA, the European cosmetics industry association
7. ASEAN Guideline for Cosmetic Good Manufacturing Practice

A manufacturer's ISO 22716 certificate is therefore direct evidence an importer can use, and it is the document most often received from suppliers in Europe, Korea, Japan and China. Annex B also sets other importer duties linked to manufacturing, for example:

• a letter of authorization from the brand owner or manufacturer; see Letter of authorization for the Thai FDA;
• a Certificate of Analysis (COA) or a document showing product conformance, kept in the Product Information File (PIF) for three years after the expiry date or five years after the manufacturing date;
• customs declarations and invoices showing batch numbers kept for five years after import, and retained samples of imported products kept at least until their expiry date.

The full import document list is in Cosmetic import documents checklist, and the import process from the beginning is in Importing cosmetics to Thailand.

How to check an ISO 22716 GMP certificate

Certificates sent by manufacturers usually arrive as a one-page PDF, and at a glance they all look alike. What makes a certificate unusable tends to be in the details. Before you file it, check at least these six points.

1. Factory name and address must match the manufacturer named in the letter of authorization, the COA and the data you will use for notification. If the parent company has several plants, the certificate must belong to the plant that actually makes your product.
2. The standard named must be ISO 22716, not ISO 9001 or ISO 14001, which are sometimes attached alongside.
3. Scope of certification must cover the activities and product types you buy, for example manufacturing and filling of skin care products. If the scope only mentions filling or storage, the bulk product may be made elsewhere.
4. Issue and expiry dates: the certificate must be valid on the day you submit documents, and you should request the renewed certificate before it expires.
5. The certification body: check whether it is accredited by an accreditation body and whether the certificate status can be verified in the certification body's database.
6. Consistency with other documents: batch numbers on the COA must match the goods imported, and the manufacturer's name must be spelled the same way on every document.

The import document checker reads GMP certificates, letters of authorization and other supplier documents, then tells you whether the manufacturer name matches across all of them and which documents are still missing, which saves a lot of manual cross-checking.

Hiring a cream manufacturer: GMP questions to ask before you sign

Most brand owners do not manufacture themselves; they hire a factory to make their creams, lotions or serums. Before signing with a factory, these are the questions worth asking about manufacturing standards.

• Has the manufacturing site passed inspection under the 2018 notification, and can it be used for notification in the client's name?
• Does the factory hold ASEAN Cosmetic GMP certification from the Thai FDA or an ISO 22716 certificate? Ask for a copy together with its scope.
• If the factory has several sites, where exactly will your product be made, and is that site covered by the certificate?
• Can the factory hand over batch records, COAs and stability test results? These documents belong in your PIF.
• If the factory subcontracts any step, such as filling or testing, is the subcontractor under the same quality system?
• How does its complaint and recall procedure coordinate with the brand owner?

A factory's standard does not release the brand owner from legal duties. The notification holder remains responsible for the formula, the label and product safety. Who holds the notification when production is outsourced is explained in Cream OEM: who owns the notification, and the overall picture of starting a brand is in Legal checklist for starting a skincare brand.

A word on communication: a factory certificate does not mean the product delivers the benefits advertised. Advertising should not lead consumers to believe that a government agency has certified the product itself. If you mention a manufacturing standard, state accurately that it applies to the manufacturing site.

Factories aiming for ISO 22716: where to start

For a factory that already meets the premises requirements and wants to move up to ISO 22716, a workable sequence is:

1. Gap assessment: compare current practice with the 15 areas of ISO 22716, one by one. Small factories most often lack change control, deviation handling, equipment calibration and internal audits.
2. Write and revise documents: quality manual, standard operating procedures (SOPs), master formulas, batch record forms and raw-material receiving records.
3. Train staff: everyone involved in production should understand why each step exists, not just how to fill in the form.
4. Run the system and collect evidence: operate under the new system until several batches have complete records.
5. Internal audit and management review: find your own gaps before an external auditor does.
6. Choose a certification body and be audited: pick a body your customers or target markets recognise, and close every finding.

If your goal is to sell within ASEAN or to domestic brand customers, ASEAN Cosmetic GMP from the Thai FDA may be the better fit. If your customers are international brands or you plan to export to Europe, ISO 22716 is usually the certificate requested. Many factories hold both, built on a single set of documents.

If you would like our consulting team to review your site and documents or help set up the system, see factory setup services or contact us.

Sources

1. Cosmetic Act B.E. 2558 (2015) · Open source · Search our archive
2. Ministry of Public Health notification on criteria, methods and conditions for manufacturing or importing cosmetics B.E. 2561 (dated 4 May 2018) · Open source · Search our archive
3. Thai FDA guide to site inspection under the 2018 notification on manufacturing or importing cosmetics (revision 2) · Open source · Search our archive
4. Thai FDA regulation on cosmetic GMP certification (RL-CH4-1, revision 2, effective 9 December 2025) · Open source · Search our archive
5. Thai FDA manual for auditing manufacturing sites against the ASEAN Guidelines for Cosmetic GMP (revised May 2021) · Open source · Search our archive
6. List of inspection bodies for ASEAN Cosmetic GMP audits · 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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