Qualification
& Engineering

The act of Validation, originally addressed only to sterilized equipment, now involves all product, process and facility matters.
Choose PQE's solutions to ensure that your plant site meets your business objectives while being fully compliant with the latest Good Manufacturing Practice regulations and standards.

Discover our solutions

Commissioning & Qualification

Make sure all equipment, facilities and systems are always fit for their intended use and avoid the risk of adulterating products.
Demonstrate and document that the critical manufacturing facilities, systems, utilities, and equipment are suitable for the intended purpose uses requirements.

Quality Engineering

In our design methodology, GMP compliance meets the latest concepts for Lean manufacturing, operation flexibility and modular design. The expertise of professionals working in the Life Science arena for more than 15 years is merged together with our engineers and architects' know-how, to reach the best-in-class solution for our customers.

An integrated approach

Our Quality Engineering and C&Q teams are working together in order to provide our customers with an integrated full service approach delivering.

  • Facility design based on business needs and GMP constraints
  • Leverage of supplier testing as much as possible
  • Qualification solution based on the latest regulatory requirements and guidelines
  • Minimization of time and costs assuring sustainable compliance

Focus on: Annex 1

With the release of the Second Issue of 2020 GMP Annex I, the standard for all sterile manufacturers has been widely extended and revised.
PQE Group has collected all the informations you need to comply in an exhaustive guide. Don’t wait: request the download now for free and get all the insights on sterile assurance.

Want to know more?

Flyer

Read our quick flyer guide about PQE Group's turnkey solutions, methodology and approach for Quality Engineering.

Webinar

Browse our Knowledge Gallery and view our free online seminar about Engineering and Strategic site master plan.

Flyer

Read our quick flyer guide about PQE Group's turnkey solutions, methodology and approach for Commissioning and Qualification.

Why PQE?

PQE Group, with multidisciplinary teams with and integrated knowledge in sterile production, oral solutions and more, can support clients with cost effective engineering solutions for Pharmaceutical, APIs, Biopharmaceutical and MD facilities to ensure that the related regulatory requirements set by FDA, EU GMP and others are met.

Full Service Portfolio

Qualification & Engineering Full Service Portfolio

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We will be more than happy to help you find the most suitable solution for your business.