Stewart & Associates specialise in sterile manufacture and oral dosage forms, including:
GMP audits in preparation for WHO, PICs and EU inspections,
CAPA, RCA, QRM and problem solving,
Quality Management Systems and QC laboratory reviews, and
Training Programs. (Sterile Manufacture, OOS investigations)
We offer expertise in the management of:
Disinfection practices,
Sterility Failures,
HVAC systems,
Water for injection issues, or
Preparing for, and responding to regulatory authority audits.