Reference project

Cleanroom qualification for cytostatic drug manufacturer

A manufacturer of industrially produced, patient specific pharmaceutical infusion solutions is adapting its production environment to meet new requirements. As part of the project management, EXCO reduces the workload for the client when procuring new cytostatic drug workbenches. The workrooms, the cleanroom and the cytostatic drug workbenches are qualified by EXCO.


Implementation
  • Support when selecting the suitable supplier for the cytostatic drug workbenches
  • Support during drafting of the contract with the supplier
  • Structuring of the qualification procedure:
    • Design Qualification (DQ)
    • Factory Acceptance Test (FAT)
    • Site Acceptance Test (SAT)
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
  • Creation of qualification documents (plans, protocols, reports)

We undertake the task of cleanroom qualification so that our clients can concentrate on their core business.

Anett Müller, Head of Unit Process Qualification - Process Technology

Customer benefits
  • Relieving the client’s workload through EXCO‘s expertise in QA regulations, GMP guidelines and legal specifications.
  • EXCO takes over all aspects of supplier coordination.

Client

Pharmaceutical company, Münster

Expert contact

Anett Müller

T+49 6233 73778-128