Objective
Providing GMP compliance oversight to the process scaling-up and validation of a complex biosimilar manufacturing by a qualified contract manufacturing organization, up to Marketing Authorization Application filing, responses to the queries from the Competent Authorities and final successful registration
Outcome
- Comprehensive process characterization
- Ancillary activities including equipment qualifications and cleaning validations
- Successful completion of the process validation runs
- Assessment and management of all process-related and non process-related deviations and changes over the course of the PPQ runs
- Compliance strategy determination towards successful filing of the process validation package