Qualification and validation of production processes play
an essential role in the pharmaceutical industry in particular
but are just as important in the cosmetic and food industry.

Our goal is to build on the EMP company expertise in the fields
of electrical, instrumentation and control technology
and process control engineering and ensure consistent
qualification (DQ, IQ, OQ, PQ).

The validation of the complete system includes:
 

  • Qualification of the control system (together with field level)
  • Qualification of the production system and method
  • Examination of the entire system
  • Provision of detailed and comprehensible
    documentation
  • Creation of Validation Master Plans
  • Creation of Master Qualification Plans
  • Tender specification and requirements specification
  • Risk Analysis / Qualification Need Analysis
  • GMP Review and FDA Pre-Approval Support
  • Design Qualification DQ
    (Creation and execution of:)
    • Installation Qualification IQ test plans
    • Operational Qualification OQ test protocols
    • Performance Qualification PQ reports
    • Validation support


In addition to the standard training services we offer additional
services based on our EMP expertise, these include supplier auditing
and creation of SOPs and policies, for example determination of
the strategy for the qualification of computerized systems.


EMP services:

  • Auditing:
    • System audits
    • Product audits
    • c-GMP audits
  • Development of standard operating procedures (SOPs)
  • Creation of regulations (policies