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Explainer · September 16, 2014

GMP Certification on Labels: What It Does Not Prove

By the editorial panel · Vietnam Trusted Brands

GMP certification on a supplement label tells you something about a factory. It does not tell you how well the product inside the bottle will work. Many buyers read the three letters as a stamp of quality for the product itself. That is a bigger promise than the certificate makes.

What GMP actually means

GMP stands for Good Manufacturing Practice. The World Health Organization's GMP guide for medicines describes it as the part of quality assurance that makes sure products are made and controlled to quality standards suited to their intended use. That guide is written for medicines, but it is the best known statement of what GMP means. Its main aim is to cut the risks that come with any production line.

The WHO names two big risks. One is cross-contamination, where an unexpected substance gets into a batch. The other is a mix-up, such as the wrong label on a container. GMP is a set of habits that keeps both risks small.

Sources: WHO Technical Report Series No. 961, Annex 3, "WHO good manufacturing practices for pharmaceutical products: main principles" (2011), listed on the WHO medicines quality page, section 2.

What a GMP system covers

The WHO guide lists what a factory needs in place. Processes must be clearly defined and checked against experience. Staff must be trained and qualified. Premises, equipment, storage and transport must be suitable. Instructions must be written in clear language.

Records matter just as much. Under the WHO guide, a factory keeps records during manufacture to show that each required step was taken. It records and investigates any serious deviation. It also keeps records that let it trace the full history of a batch.

Notice what is missing from that list. Nothing in it promises a result for the person who uses the product. GMP is about process, people, places and paperwork. It is a claim about the factory.

Sources: WHO Technical Report Series No. 961, Annex 3, "WHO good manufacturing practices for pharmaceutical products: main principles" (2011), listed on the WHO medicines quality page, section 2.

What it does not prove

A GMP certificate does not prove that a product is right for you. It does not prove that the label claims are true. It does not rate one brand above another. Two products from two certified factories can differ a great deal in their ingredients and in how they are marketed.

It also does not cover every day. A certificate reflects a visit at one point in time. A factory can change its staff, its equipment or its suppliers after that visit. A certificate on a label is a starting point for questions, not the end of them.

The WHO guide itself says that its practices are general guides that may be adapted to individual needs. It also leaves out some topics, such as the safety of workers and protection of the environment. These are normally handled by national law.

Sources: WHO Technical Report Series No. 961, Annex 3, "WHO good manufacturing practices for pharmaceutical products: main principles" (2011), listed on the WHO medicines quality page, general considerations.

Who looks after supplements in Vietnam

In Vietnam, the Law on Food Safety, passed by the National Assembly in 2010, is the base for food rules. It treats supplements as a kind of functional food, next to health protection foods and medical nutrition foods. The Minister of Health sets how functional foods are managed, and the Ministry of Health oversees their food safety from production through trade and import.

The law also sets basic conditions for places that make or sell food. These include suitable premises, enough clean water, proper equipment, waste treatment, records of where food comes from, and staff who meet health and knowledge rules. A food safety certificate is granted when a business meets the required conditions, and it is withdrawn when it stops meeting them.

The same law asks the state to build a legal framework and a plan to make GMP and similar systems mandatory in food production and trade over time. In other words, GMP is a direction of travel for the sector, and a buyer should not assume every maker already follows it.

This is general information only. For how these food laws apply to one product or business, ask a Vietnamese food regulatory lawyer.

Sources: Law No. 55/2010/QH12 on Food Safety (National Assembly of Vietnam, 2010), Articles 2, 4, 14, 19, 34, 35 and 62.

How to check a GMP certification

Use these steps before you rely on one.

  • Find the name of the body that issued the certificate. A certificate with no issuer is only a picture.
  • Check that the factory address on the certificate matches the factory named on the product.
  • Look at the date the certificate was issued and the date it runs to.
  • Ask the seller for a copy of the full document, not just the logo.
  • Confirm with the issuing body that the certificate is real, using contact details you find yourself, not details printed on the seller's page.
  • Check that the certificate covers this kind of product, since some certificates cover only certain product lines.

A seller with nothing to hide will answer these questions quickly. A seller who goes quiet has told you something useful.

The short version

Treat GMP certification as proof of one thing: a named factory, checked by a named body, follows set rules for how it makes products. That is worth knowing. It is not a promise about what the product will do for you. Keep the certificate in the file next to the other documents you collect, and judge the product on all of them together.

This article gives general information only. Before you take any supplement, a doctor or pharmacist can tell you whether it suits your health.

A place on this register is not for sale.

Filed September 16, 2014 · All news · Methodology