GMP & GCP Quality Enablement
Tech-enabled quality systems, audit frameworks, and inspection readiness
From early clinical development through commercial supply, Celito enables quality operations through standardized quality systems, proprietary accelerators, and inspection-ready governance frameworks that reduce regulatory risk across manufacturing and clinical programs.
Why GMP & GCP Compliance Matters
Whether producing clinical material or running multi-site trials, inconsistent quality systems and manual processes increase inspection risk and operational disruption. Celito deploys standardized GMP and GCP quality frameworks and technology enabled controls that enable predictable compliance and regulatory confidence across FDA, EMA, and MHRA inspections.
What We Deliver
GMP Quality Assurance
- Facility and process gap assessments using standardized evaluation frameworks aligned to current FDA and EMA expectations.
- Phase-appropriate SOP libraries and document frameworks that scale from engineering runs through commercial launch.
- Supplier and CMO audit programs covering qualification, ongoing surveillance, and quality agreements.
- Data integrity controls aligned to ALCOA+ principles embedded across batch records, LIMS, and manufacturing systems.
GCP Quality Oversight
- Risk-based GCP quality oversight models aligned to study complexity and regulatory expectations.
- Clinical investigator and service provider audit frameworks supporting compliance, safety, and TMF accuracy.
- Inspection readiness programs including mock interviews, document triage, and coordinated response management.
- CAPA management workflows with corrective actions, effectiveness verification, and quality dashboards.
Audit & Inspection Readiness
- Mock inspections executed using standardized inspection playbooks and readiness criteria.
- Evidence management workflows supporting live inspections and rapid issue triage.
- End-to-end CAPA tracking and closure supported by quality dashboards and governance controls.
Continuous Quality Improvement
- Quality KPI dashboards providing visibility into deviations, CAPAs, batch records, and eTMF completeness.
- Root-cause analysis and preventive action frameworks embedded into quality operations.
- Role-based training programs aligned to evolving regulatory requirements and organizational responsibilities.
Our 4‑Step Methodology
Assess
Baseline GMP/GCP audit, risk scoring, and prioritized remediation roadmap.
Architect
Future-state process flows and Role × System × Data blueprint.
Implement
SOP authoring, validated configuration, migration, and staff training.
Advance
Metrics reviews, periodic internal audits, and continuous-improvement cycles.
Flexible Ways to Engage
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Model
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Typical Use Case
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Commitment
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|---|---|---|
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Quality Accelerator Program
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Series A–C biotechs requiring structured GMP and GCP quality system uplift
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16 weeks
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Quality Leadership Operating Model
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Leadership plus inspection prep
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1–2 days / week
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Audit & Inspection Support
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Global audits, service provider oversight, and structured inspection response support
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Project-based
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Analytics Accelerator
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Quality dashboards and signal detection across clinical and manufacturing data |
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6‑8 weeks
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Proven Outcomes
Zero major observations across multiple FDA and EMA inspections.
25% faster deviation closure after implementing our KPI dashboard.
90% CAPA effectiveness within the first audit cycle.