Protocols and Methods Adapted to Your Processes
Each pharmaceutical company relies on a quality system specific to its reality. Genipro easily adapts to your practices so that the qualification and validation work harmonizes with your existing processes.
Validations That Pay Off
When well planned and successfully completed, qualification and validation work is a seal of compliance of your equipment and manufacturing processes, as well as a stepping stone towards the rapid achievement of your business goals. This is the final step in the quality control of the facilities that will serve to make your investment pay off.
Our priority is to establish realistic, attainable and repeatable acceptance criteria.
Our achievements
Qualification of new laboratory instruments
Pharmaceutical
Cleaning validation for a new pharmaceutical molecule
Innovative semi-solid form pharmaceutical manufacturing and packaging plant
Definition and Qualification of a New WFI System
Industrial
Definition and Qualification of a New ISO7 Manufacturing Suite
Industrial
Definition of GMP Requirements for a New Aseptic Ointment Filling Line
Pharmaceutical
Validation of a serialization system migration
Pharmaceutical
IT validation of a SAP software interface
Non-sterile consumer health pharmaceutical plant
Validation of an ERP system (SAP) migration
Pharmaceutical
Validation mandate in a staff loan mode
Pharmaceutical
Data integrity mitigations and remediations
Pharmaceutical
Qualification of an IT infrastructure
Sterile liquids pharmaceutical manufacturing plant
Qualification of new ventilation units
Manufacturing plant for non-sterile liquid and solid pharmaceutical products
Qualification and validation of a plant expansion
New manufacturing and packaging facility for innovative semi-solid oral pharmaceutical products