Full-Scope CQV Planning,
Protocols and Execution
What We Do
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.
❋ Where This Fits
Accelerated execution through disciplined prerequisites, sequencing, and field coordination
Right-sized protocol sets that are risk-based, defensible, and practical to execute
Fewer execution surprises through proactive issue management and turnover alignment
Inspection-ready traceability supported by closeout discipline and evidence package completeness
❋ What Prime Pharma Partners Provides
CQV planning (scope, sequencing, prerequisites, integrated milestone mapping)
Protocol development support (commissioning/qualification protocols and associated test documentation)
Field execution support (test execution support, issue/deviation triage, stakeholder coordination)
Turnover and readiness control (turnover package alignment, gating criteria)
Closeout discipline (evidence package completion and inspection-ready traceability)
❋ Common Deliverables
CQV plan / work plan (milestones, sequencing, prerequisites, readiness gates)
Protocol set development support (commissioning and qualification protocols aligned to site standards)
Execution trackers (test status, prerequisites, punch/issue management)
Evidence package closeout support (test records, deviations, reports, traceability)
❋ Outcomes
Typical phases: planning → turnover → commissioning → qualification execution → readiness closeout
Typical collaborators: engineering, CQV, automation, manufacturing readiness, QA/QC, and site leadership