What WHO-GMP certification actually means for a pharmaceutical buyer

Good Manufacturing Practice (GMP) is the set of rules that govern how a medicine is made, tested, stored and released. The World Health Organization publishes its own version, and a WHO-GMP certificate confirms that a national regulator has inspected a manufacturing site against those rules. For an importer, it is usually the first document a registration authority asks for.

What the certificate covers

A WHO-GMP inspection looks at the whole manufacturing system rather than a single product. In practice that means:

• Premises and equipment: layout, air handling, cleaning and calibration records.
• Personnel: training, hygiene and clearly assigned responsibilities.
• Documentation: batch manufacturing records, standard operating procedures and change control.
• Quality control: validated analytical methods, stability programmes and release testing.
• Handling of complaints, recalls and deviations.

The certificate is issued for a site and, in most countries, lists the dosage forms and product categories the site is approved to make. It is valid for a fixed period and has to be renewed after re-inspection.

What it does not tell you

WHO-GMP is a manufacturing standard, not a product approval. It does not confirm that a specific formulation is registered in your country, that its stability data covers your climate zone, or that the dossier is in the format your regulator wants. Those are separate questions, and a good supplier should be able to answer them for each product you are considering.

Questions worth asking a supplier

• Which site will manufacture my product, and can I see the current certificate for that site?
• Does the certificate list the dosage form I am buying?
• Is there a Certificate of Pharmaceutical Product (CoPP) available for this product?
• What stability data exists, and for which climatic zone?
• Who prepares the registration dossier, and in which format (CTD, ACTD, country-specific)?

A supplier who answers these quickly, with documents rather than assurances, is one whose paperwork is in order. That matters more than the certificate itself, because the paperwork is what your regulator will read.

How we handle it

Every product in the Pedveek range is manufactured at a WHO-GMP certified site, and the certificate, CoPP and stability summary travel with the product dossier. If you are evaluating a product, ask us for the document set for that item and we will send it.