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Good manufacturing practice (GMP)

Good Manufacturing Practice constitutes the licence to operate in pharmaceutical manufacturing everywhere in the world. But it is becoming more and more complex to meet the ever increasing regulatory requirements.

Good Manufacturing Practice is a core condition in pharmaceutical manufacturing worldwide, but not an easy task. Rules and interpretations differ from country to country, and they change frequently. If quality considerations are not integrated into your projects early enough, delays and quality issues are also certain to arise. Quality documentation and validation on the other hand demand a lot of resources.

GMP is in our DNA

Ever since Danish Novo Nordisk and German Fresenius started building pharma facilities, we have provided specialist pharma engineering skills.

We were born and raised with the process and production understanding of a pharma company. This is the foundation of our cross-technical teams of engineers, architects, chemists and pharmacists when they design,
construct, validate and start up facilities. But it also enables us to support manufacturing operations with services within optimisation, product and process development, pilot plants and laboratories.

Ensuring seamless GMP compliance

With our certified and pharmaceutically trained professionals, NNE offers you seamless fulfilment of GMP. We have the expertise and international experience to handle the ever-more complex quality demands through GMP compliant design and solutions, quality documentation and validation in projects.
We can help you achieve and maintain GMP compliance throughout the lifecycle of a product by delivering customised compliance services from problem solving to compliance achievement.
Our combination of consulting and engineering services means that we are able to develop and implement seamless GMP solutions and services that are future proof and operational. Having this in-depth GMP knowledge is what differentiates us from our competitors – we are pharma engineers, not just engineers.
Our services include:

  • Quality systems development and support
  • GMP strategy development
  • Quality support on optimisation, implementation and training
  • Audits and quality assurance services
  • Process validation services (QbD, DoE, PAT, QMR/QRA)
  • Root cause analysis and other CAPA support
  • Mock inspections/GAP analysis, and inspection readiness assessments
  • Remediation programmes
  • GMP compliance training

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