Mission Bio-Pharmaceutical Solutions, Corp.
Pharmaceuticals - North Reading, Massachusetts, United States
Mission Bio-Pharmaceutical Solutions, Corp. Employees
Mission Bio-Pharmaceutical Solutions, Corp. Details
Proudly serving as a trusted contract resource to Pharmaceutical, Biotechnology, and Medical Device clients across the New England region for:Design-Phase Planning, Facility Start-up, and Project Management: Providing CapEx project management support with focus on isolated vial and syringe filling lines, depyrogenation ovens/tunnels, steam sterilizers, washers, and lyophilizers.Computerized Maintenance Management System (CMMS) Integrations: Providing a full suite of solutions from custom work-flow and user interface development to delivery of comprehensive GAMP 5-compliant validation life-cycle documentation packages.Metrology Program Development: Providing end-to-end program development solutions for paper-based, fully electronic, or hybrid systems to establish a robust IM&TE life-cycle approach. Solutions encompass the establishment of adjustment (guard-band), calibration, and process tolerance philosophies, asset induction and control practices, and parameter/status change control procedures.Quality Assurance Validation Support : Areas of expertise include production batch record optimization for validated parameter compliance and batch-to-batch repeatability, change evaluation for validation impact per system risk priority and component level impact/criticality, and development of class-validation strategies & rationale for manufacturing process equipment.
