Quality Assurance
Full infrastructure/competencies to support responsible Quality Designate (Qualified Professional in EU for example).
Quality control and engagement with global manufacturers.
Technical Agreements, Formulation/API site Audits, APQRs, Complaints investigations, etc.
Activities leading up to Batch Release
Review of Batch records, Process validation protocol and report, deviations follow ups.
Management of country - specific site release procedures as support to Quality Designate.
Review of alternate sourcing documents
Specifications, GMP/GLP, SMF, etc.
Artwork development, working with manufacturers, maintenance via change controls.