919-827-0933

Commissioning & Qualification

“Demonstrating equipment, facilities and utilities are fit for their intended use as defined by user, regulatory and process requirements”

Qualification Approach

Regardless of what methodology you follow, a good qualification program will begin with defining how the equipment or system will be used (user requirements) and evaluating the risk of implementing the system (risk assessment) in your environment.  From there, proper planning and a robust testing process will confirm the system is capable of meeting the user and process requirements (fit for use) and applicable regulatory requirements.

    What we do?

    Mangan Biopharm offers personnel who can provide commissioning and qualification support for your systems, utilities and equipment supporting GxP activities in the heavily-regulated biopharmaceutical Industry.   Whether your scope is a single system,  CQV program development, or an audit of your existing program against current industry standards, Mangan can provide resources to fit your specific needs.

    Risk Based Approach

    Applying a  proper risk based approach to commissioning & qualification is a critical step in a robust qualification life cycle.  From the initial development of the User Requirements Specifications (URS) through system testing, release, and retirement, risk evaluation should be an integral part of your process.  Let Mangan help you integrate a risk based approach into your current program.

    Why choose Mangan?

    After twenty years of providing services to our clients, our personnel have the expertise to work with you on projects of all sizes.  Regardless of project scope and size, Mangan Biopharm can provide expert professional services to deliver projects on time and on budget without sacrificing quality.  Our business is customer satisfaction. 

    Resources

    System Experience

    Biotechnology Equipment

    • Chromatography Skids
    • Filtration
    • Bioreactors
    • Vial Washers
    • Depyrogenation Tunnels
    • Lyophilizers
    • Filling Lines
    • Capping Machines
    • Autoclaves
    • Isolators
    • Parts Washer
    • Mixers
    • Packaging Lines

    Utilities

    • WFI Storage and Distribution
    • Purified Water
    • Process Gases
    • Clean Steam
    • HVAC
    • CIP Skids

    Facilities

    • Room Qualification
    • Process Flow Diagrams

    Solid Dose Equipment

    • Mixers
    • Granulators
    • Fluid Bed Dryers
    • Mills
    • Tablet Presses
    • Tablet Coaters
    • Tablet Inspection Machines
    • Tablet Drilling Machines
    • Packaging Lines

    Temperature Controlled Units

    • Freezers, Refrigerators, Incubators, Stability Chambers
    • Warehouses
    • Cold Rooms
    • Trailers
    • Particle Monitoring Systems
    • Packaging Lines

    Commissioned Systems

    • Chilled Water
    • Heating Hot Water
    • Cooling Towers
    • Instrument Air
    • Waste Treatment

    Resources

    Example Projects

    Process Development Laboratory CQ&V

    Process Development Laboratory Commissioning, Qualification and Validation Duration- 14 months Overview: Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new PD laboratory, within an existing biopharmaceutical commercial/clinical...

    Cell Culture & Purification Manufacturing Suites CQ&V

    Cell Culture & Purification Suites Commissioning, Qualification and Validation Duration- 12 months Overview: Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new Cell Culture and Purification manufacturing suites within an existing...

    Clinical Manufacturing Suite and QC Laboratory Buildup

    Clinical Manufacturing Suite and QC Laboratory Buildup Duration- 12 months Overview Built and started a clinical manufacturing suite and supporting QC laboratory for a clinical stage pharmaceutical company.  The engineering scope of work involved process, mechanical...

    Contact Us

    If we can help you in any way, please complete the  More Information form and one of our specialists will contact you to discuss your specific needs and how Mangan can help you achieve your project goals.

    West Region

    trahimian@manganinc.com

    (310) 835-8080 Ext. 217

    3901 Via Oro, Long Beach, CA 90810

    Eastern and Midwest Regions

    mtedder@manganinc.com

    (919) 827-0933

    201 Shannon Oaks Circle Suite 125 Cary, NC 27511

    For More Information: