OUR TRACK RECORD
Proven Experience Across Complex GMP Programs
Where execution control matters most. Leading complex GMP manufacturing programs from construction completion through CQV to inspection‑ready closeout.
REPRESENTATIVE ENGAGEMENTS
Program Highlights
A selection of representative engagements illustrating the depth of our expertise.
Enterprise GMP Readiness & CQV Program Leadership – Sterile Drug Product Facility (North Carolina)
Scope Summary:
Led integrated CQV and GMP readiness execution across Engineering, MS&T, Automation, Quality, and Manufacturing for a sterile drug product facility.
Established and governed execution strategy from construction turnover through qualification, including prerequisite alignment, dependency management, and controlled closeout.
Directed aseptic readiness program, including APS (media fill) strategy development, planning, and cross-functional alignment to meet site and regulatory expectations.
Drove visual inspection program readiness, aligning equipment qualification, process requirements, and inspection strategy.
Implemented program-level governance, reporting, and escalation structures to maintain milestone integrity and proactively mitigate late-stage risk.
Developed and implemented an Integrated Master Schedule (IMS) and cross-functional dependency framework enabling leadership decision-making, resource alignment, and execution transparency.
Outcome Focus
Delivered structured, inspection-ready GMP readiness by aligning cross-functional execution, controlling dependencies, and protecting critical milestone dates.
Aseptic Manufacturing Readiness & CQV Leadership – Biotech Manufacturer (Boston Area)
Scope Summary:
Led APS (media fill) readiness and cross-functional execution planning to support sterile manufacturing startup and regulatory expectations.
Directed critical utilities readiness strategy, including Water for Injection (WFI) generation, storage, and distribution systems, ensuring alignment with GMP and operational requirements.
Established CQV execution framework aligned to schedule-driven milestones, integrating engineering, validation, and quality deliverables.
Drove issue resolution and risk management processes tied to readiness gates, enabling controlled progression through qualification and startup phases.
Aligned cross-functional stakeholders on execution priorities, resource planning, and readiness deliverables to maintain milestone adherence.
Supported development of inspection-ready documentation and evidence packages across utilities and aseptic processing systems.
Outcome Focus
Enabled predictable, inspection-ready startup through integrated CQV execution, disciplined risk management, and alignment of critical utilities and aseptic processing systems.
How Prime Pharma Partners Executes
Phase 1 - Lead and Govern:
Establish program control through integrated governance, clear ownership, and structured decision-making. Implement execution frameworks, meeting cadence, and schedule visibility to align all stakeholders.
Phase 2 - Plan and Execute:
Define and drive execution through integrated CQV planning, dependency management, and cross-functional alignment. Ensure all activities are structured, sequenced, and aligned to GMP readiness milestones.
Phase 3 - Stabilize and Deliver:
Resolve execution gaps, manage risk, and drive disciplined closeout to ensure inspection-ready systems, documentation, and operations. Maintain control through final readiness and transition to GMP execution.
Selected Capabilities Demonstrated
End-to-end CQV execution strategy and delivery.
Integrated program governance and execution control.
Aseptic and APS strategy development and execution.
Visual inspection program design and readiness.
Critical utilities qualification and operational reliability.
Operational readiness and inspection execution.