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.
