Cphem | Модель

Qualification

Process and product safety is always a priority for us. 

We guarantee compliance with GxP’s and official requirements (FDA, EMA, etc.) in accordance with current standards in the construction and conversion of entire plants or plant components in the pharmaceutical industry.

We aim for the complete and comprehensible documentation of all GMP-relevant processes or process steps and the assistance of our customers beyond project completion.

An overview of our services:

  • Creation of qualification concepts 
  • Creation of risk analyses 
  • Creation of qualification schedules 
  • Performance of DQ, IQ and OQ 
  • Extension of qualification phases with FAT and SAT 
  • Assistance in PQ 
  • Operator training at the plant 
  • Creation of SOPs 
  • Change control

Model Features