GxP Compliance
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 standardised 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.
Further information on this topic and related topics can also be found in the following publications:
Link to: Glatt wins follow-up order for BioCampus MultiPilot
Copyright: ZVH Straubing
December 2023: Glatt wins follow-up order for BioCampus MultiPilot in the port of Straubing-Sand
Link to: Glatt selected for Engineering Project for new GMP Biorefinery by NSTDA in Thailand
August 2022: ‘Glatt selected for Engineering Project for new GMP Biorefinery by NSTDA in Thailand’
Link to: Moving the production of biopharmaceuticals to Asia
Copyright: Magzter Inc.
Published article: ‘How to move biopharmaceuticals productions smoothly and quickly into Asian markets’ PDF, Englisch
Link to: High containment for solid drugsCopyright: Vogel Communications Group
Published article: ‘High Containment Processes in the Solid Drugs Production’ PDF, Englisch
Latest News
Glatt Engineering @ Future Factories Roadshow 2025January 15, 2025 - 12:04 pm- Glatt Automation. ISPE 2024December 5, 2024 - 7:39 am
- Structured planning and construction of biotech plants. BioEconomy Cluster 2024November 28, 2024 - 10:28 am
- Copyright: Wiley-VCH GmbHModular production systems for novel drugs like ATMPsNovember 6, 2024 - 12:30 pm
- Copyright: Vogel Communications GroupCleanroom design. Doors, glazing, walls, fixturesAugust 22, 2024 - 3:14 pm
Copyright: Wiley-VCH GmbH
Copyright: Vogel Communications Group