Safe products from your GMP-compliant production environment by Glatt Process & Plant Engineering.

There is no pharmaceutical or biotechnological production without GxP compliance

GxP-compliant planning and implementation is a matter of course for Glatt Process & Plant Engineering. This is our focus, because without GxP compliance, no pharmaceutical or biotechnological production is possible. That is why we consider all relevant GMP requirements in the project:

• Route relationships in layout planning to avoid cross-contamination
• HVAC concepts to protect personnel and/or product
• Quality assurance system requirements for the qualification and validation of equipment and systems or
• Questions of standardized documentation
• are just a few aspects of relevant GxP requirements.

We utilize our knowledge of the content and requirements of the GxP guidelines and our knowledge of GxP-compliant implementation options, which we continuously keep up to date. We use our own quality management system to document relevant improvements or solutions from the GxP environment for example by obligatory project reviews.

GxP expert knowledge in theory and practice

There is not just one solution for GxP compliant production, but there is one best possible solution. As an active member of the ISPE, we are always up to date when requirements change or are discussed. We present our own GxP compliant project approaches and learn first-hand about other GxP compliant solutions that have been realized.

‘Dry’ theory and real project practice thus experience a symbiosis that can be just useful for your project.

Use our expertise not only for the planning of new plants or greenfield projects, but also for a GMP upgrade for your

• Equipment and systems
• GMP-compliant production environments
• Personnel and material airlocks etc.

GxP compliance is for Glatt Process & Plant Engineering a basic principle for the planning and realization of projects and a fundamental KPI for talking about a successful project.