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Knowledge centre · Validation · 2026-09-19

Validation protocols for pharmaceutical filling: IQ, OQ and PQ explained

IQ, OQ and PQ are the three validation stages that prove a pharmaceutical filling machine performs consistently. Here is what each one tests and how to prepare for them.

IQ, OQ and PQ are the three validation stages that prove a pharmaceutical filling machine performs consistently. Here is what each one tests and how to prepare for them.

Validation — IQ, OQ and PQ — proves a filling machine performs consistently before it enters production. Each stage tests different aspects of the installation and process.

What to consider

  • IQ verifies installation against the specification.
  • OQ confirms the machine operates correctly across its range.
  • PQ demonstrates consistent performance on the actual product.
  • Documentation from the supplier accelerates your validation programme.

Common pitfalls

  • Skipping OQ and going straight to PQ.
  • Accepting supplier validation reports without witnessing tests.

Questions to ask your supplier

  • What validation documentation does the supplier provide?
  • Are IQ/OQ protocols included with the machine?

Pharmaceutical filling machines must pass installation qualification, operational qualification and performance qualification before they can be used in production. What each stage tests and how to prepare.

Facts used in this article: filling accuracy ±0.5% (error ≤1 g) for pure liquids and homogeneous products (error ≤1 g); measured ±1 g to ±2 g (measured) on products with particles, high viscosity or non-uniform texture (the actual value depends on product state, particle size and density uniformity); viscosity coverage ≈50–300,000 cSt; GTX series fill range 5–300,000 ml. These are the published manufacturer figures also stated on our specifications page.
Questions about this topic for your own product? wangaiguo@grountonpak.com · Tel +86 133 9317 7755

Built for your product — Grounton Pak

Grounton Pak (Hebei Guangteng Machinery Equipment Co., Ltd., brand GROUNTON) has built metering-grade rotor pump filling machines since 2013 — more than 40,000+ units delivered, with ±0.5% filling accuracy for pure liquids and measured ±1 g to ±2 g (measured) on particle-containing or high-viscosity products, CIP-capable hygienic construction and custom filling lines.

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Email: wangaiguo@grountonpak.com · WhatsApp: +86 133 9317 7755