GMP Services

Good Manufacturing Practice, GMP

Special requirements in GMP-regulated fields form daily challenges for to our team and we are proud of our on-site projects as well as numerous prototypes and special machines in automation.

 

 

On-site, our strengths lie in:

GMP Project Management

Reliability and quality – core values of "Good Manufacturing Practice" – and our mission. Therefore, our experts feel particularly comfortable in the field of medical technology applications and offer you at any time their dedication and competence for your projects:

  • Project management, project control
  • Project coordination
  • Supplier support
  • Planning and monitoring
  • Industrial engineering
  • Change management
  • Execution of FMEAs
Project management GMP

Qualification / Validation / Compliance

Our experts are ready to ensure your system's operation, product quality, and compliance with all requirements.

  • Qualification and validation of
    • Equipment
    • Prototypes
    • Production systems (Systems 21CFR/Part 11)
  • Changes
  • Use of document management systems
  • Creation and correction of SOPs
  • Failure management CAPA
  • Product, process or computer system validation
  • Cleaning validation
Qualification / Validation / Compliance

Documentation

In medical technology, as well as in the pharmaceutical or food industry, documentation in compliance with standards is an essential precondition to protect our health. Our experts are specialized in

  • Validation plans VP
  • User Requirement Specification URS
  • Functional Risk Analysis FRA
  • GMP risk analyses
  • FMEA
  • IQ, OQ, DQ, PQ
  • FAT, SAT
  • Final reports
  • Tools: TrackWise, Windchill
Writing a documentation

Further competence areas

Additional project management competencies:

Project management in many areas