Qualification and validation are a central part of the quality at CARBOGEN AMCIS. They ensure that buildings, rooms, materials, equipment, processes and methods as well as the level of training of our personnel match the GMP requirement of the national and international guidelines (SwissMedic, FDA, ICH Q7A, etc.).

Our Validation Master Plan clearly defines and describes all qualification and validation activities and assigns responsibility for each of these activities.

The following elements are covered by the Master Plan:

Qualification

• Rooms
• Systems
• Equipment for manufacturing and for development
• Computer systems

Maintenance

• Rooms
• Computer
• Systems
• Equipment

Validation

• Process Validation
• Cleaning Validation
• Method Validation

Documentation

• Batch Records, training documents, etc.
• Change Control
• Deviation

Change Control

Training

Project Documentation Structure  

• Master plan - for each project (describing project activities)
• Development protocol and report
• Implementation protocol for scale-up and production
• Process validation plan and report
• Cleaning validation plan and report
• Recovery studies plan and report
• Special studies e.g. Endotoxine, TOC, safety, etc.