Implementation of GMPs for New Clinical Manufacturing Area

A team of GMP Consultants were mandated to set up and manage GMP processes (Deviation, CAPA, Change Control, Batch Record), procedures and training for the new clinical manufacturing areas for high quality proteins and biomolecules at a biotech company. Validation experts on the team were responsible to create and execute validation protocols for equipment qualification, issue reports and related deviations.

The project resulted in the successful manufacturing, packaging and testing of a COVID vaccine for clinical trials.