By Pulse Pharma Mfg Co.2 min read
In this article
Almost every pharma manufacturer says it is WHO-GMP and ISO certified. The two certificates are different and each one answers a different question. Knowing the difference helps you ask better questions.
What GMP means
GMP stands for Good Manufacturing Practice. It is a set of rules for how medicines are made: clean and suitable premises, trained staff, tested materials, written procedures and complete records. Its purpose is to make every batch consistently safe and of the right quality.
What WHO-GMP means
WHO-GMP refers to the GMP guidelines published by the World Health Organization. A plant that follows them shows that it works to an internationally recognised standard. A WHO-GMP certificate is usually issued by the drug regulator after inspecting the site. Importers, institutions and tenders often ask for it.
What ISO 9001:2015 means
ISO 9001:2015 is a quality management system standard. It covers how an organisation runs its processes: documentation, responsibilities, audits, corrective action and continual improvement. It is not specific to medicines and it does not test any product.
The difference in one line
- WHO-GMP is about how medicines are made and controlled in the plant.
- ISO 9001:2015 is about how well the whole organisation manages quality.
A manufacturer benefits from both. Neither guarantees a particular batch on its own.
What certificates do not tell you
A certificate shows that a system exists. It does not show that your product is made well. Ask also about:
- Testing: which tests are done in-house and which outside?
- Batch records: are they complete and checked before release?
- Complaints: how are quality complaints recorded and resolved?
- Experience: how long has the plant made your type of product?
How to read a certificate
Check the name and address of the site, the scope, the date issued and the expiry date. A certificate for a different address or an expired one does not help you.
Ask to see the document. A good manufacturer will show it without hesitation.
How Pulse Pharma works
Pulse Pharma follows WHO-GMP compliant practices and holds ISO 9001:2015 certification. We test raw materials and finished products in our in-house lab with HPLC and UV spectrophotometer analysis before packing. See how this fits into the plant and quality pages, or read the 10-point checklist for choosing a manufacturer.
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