Facility-Wide Legacy Equipment Qualification

Design Group was engaged by a top ten pharmaceutical manufacturer to develop and execute Installation and Operational Qualifications, Engineering Studies, and Commissioning Documents for over 300 individual pieces of legacy packaging and manufacturing equipment over a 2.5-year period.

New Facility Qualification

Design Group provided engineering startup support for a custom batching, transdermal assembly, pouching, laser/vision inspection and downstream packaging equipment. Regulatory Services incorporated the development and execution of Design Specifications, Traceability Matrices, Commissioning Documentation, Operational, Maintenance, Cleaning and Startup Procedures, Installation Qualifications and Operational Qualifications for approximately 30 systems as well as purified water, utility, BMS and site security systems. Provided higher level Quality Systems direction for SOP development, calibration requirements, documentation formats, batch record requirements, etc., for a Greenfield GMP regulated manufacturing facility.

Additional Representative Projects

• Quality System Implementation, SOP Development, Manufacturing and Lab Methods Validation for a Medical Film Manufacturer
• SAT, IQ OQ and PQ Services for New Clinical Manufacturing Facility
• Plant-Wide cGMP Gap Assessment for a Leading Pharmaceutical Manufacturer
• Specification, Commissioning and Qualification of Complex Systems for Solvent Coating, Near-Infrared and Color Vision Attribute Inspection
• Quality Systems Assessments for a Major Drug Manufacturer