Commissioning and Documentation
The theme "GMP-compliant documentation for pharmaceutical technology" has become a focal point of interest, not least because of the multitude of inspections by official bodies. Kramer & Best concentrate on the implementation of GMP-compliant guidelines in advance and manage the documentation from the planning to the routine operation – GMP-compliant qualification documentation – document changes (change control).
Commissioning
- Documentation of tests
- Test operation
- Staff instruction
Guaranteed Quality from Initial Contact to Commissioning
- GMP I FDA compliant from the incoming goods inspection to the endoscopy
- Measurement of surface roughness
- Measurement of delta ferrite
- Measurement of residual oxygen
- Endoscopic welding
- Pressure recorder
- Radiography and/or ultrasound, material testing by independent test laboratories
Piping and Welding Documentation
- Process -controlled integration of material certificates
- Isometric parts lists, in CAD on request
- Welding data logging of actual values
- Welding protocols
