Program Governance & CQV Leadership for Complex GMP Manufacturing
Prime Pharma Partners provides program architecture, integrated scheduling, and CQV leadership that brings structure, accountability, and delivery control to pharmaceutical and biotech capital programs, accelerating readiness from Construction Completion → CQV → GMP Release.
Capital & CQV
Program Delivery
Programs led from construction completion through GMP readiness.
10+
Years of Technical Program Leadership
10+ years operating at the executive interface and in the field.
Global Pharma & Biotech Leaders Supported
Trusted by leading global manufacturers across drug product and advanced therapies.
Our Services
Full-Scope CQV Planning, Protocols and Execution
Prime Pharma Partners provides full-scope CQV strategy, planning, protocol development, execution, and closeout for all equipment classes, utilities, automation platforms, and manufacturing systems used in commercial GMP operations. This includes IQ/OQ/PQ authoring, FAT/SAT support, deviation resolution, execution oversight across utilities, facilities, equipment, filling lines, and automation, and integration of ASTM E2500 principles with site Quality Systems.
Operational & Inspection Readiness
Readiness planning, mock audits, documentation alignment, SOP/validation integration, training, and complete preparation for regulatory inspections.
CQV Program Leadership
Risk-based validation strategy aligned with ASTM E2500, ISPE, and Annex 1, with oversight from FAT/SAT through IQ/OQ/PQ across equipment, utilities, facilities, and automation. Clear, structured scope translation into workplans, milestones, and ownership.
Visual Inspection Program Development
Manual, semi-automated, and automated visual inspection program design; defect libraries; program lifecycle governance; alignment with Annex 1 and site quality systems.
Critical Utilities & Technical Systems Validation
WFI, RO/DI, clean steam, gases, CIP/SIP, and facility utility systems qualification; readiness planning; complete integration with facility and quality requirements.
Aseptic Fill-Finish & APS / Media Fills
Isolator and filling line readiness, aseptic process simulation (APS/media fills), sterilization readiness (SIP), and contamination control integration aligned with expectations for sterile operations.
Integrated Program Governance & Scheduling
Development and management of L1–L7 integrated master schedules, tiered governance, executive reporting, RACI ownership, and risk/action tracking across Validation, MS&T, Engineering, Automation, and Quality.
About
Prime Pharma Partners
Prime Pharma Partners delivers technical program governance, CQV leadership, and operational readiness for complex GMP manufacturing programs. Built on experience taking projects from construction completion through CQV and GMP release, the firm establishes the structures, schedules, and accountability mechanisms that align Engineering, MS&T, Automation, Quality, and Manufacturing to deliver on time, on budget, and audit-ready.
Our Specializations:
• Program Architecture & Governance
• Risk-Based CQV Strategy
• Aseptic Fill-Finish & APS/Media Fills
• Critical Utilities Validation
• Visual Inspection Programs
• Operational & Inspection Readiness
Representative Project Experience Across Leading Pharmaceutical Organizations
Experience delivered through prior consulting roles:
Advanced Therapy Medicinal Products
Tailored validation and readiness for novel modalities.
Industries Served
Sterile Injectable Manufacturing
Fill-finish validation, isolator readiness, APS/media fills, and inspection readiness.
Cell and Gene Therapy Facilities
Small-batch aseptic operations and
CQV governance support.
Biologics
Production
Upstream/downstream equipment and utilities CQV.
Vaccine
Manufacturing
Platform readiness, qualification, and schedule-driven execution.
Advanced Therapy Medicinal Products
Tailored validation and readiness for novel modalities.
Our Partners
Research Triangle Park, North Carolina | Boston, Massachusetts
