GMP Audit Readiness for CGT Operations
Brevitas was engaged to conduct an audit-readiness assessment using a risk-based approach to identify compliance gaps and recommend a focused remediation plan to support timely licensure and GMP operational launch.
“Thank you for the constructive feedback!” – Our CGT Client
Business Challenge
Our CGT client was preparing to transition from engineering trials to GMP operations at a newly constructed facility. With a regulatory inspection on the horizon, they faced mounting pressure to demonstrate audit readiness and align with regulatory expectations.
Our Approach
Brevitas executed a focused 5-day inspection readiness assessment, designed to simulate regulatory scrutiny while fostering internal clarity and ownership. The process was collaborative and risk-based, empowering site personnel to connect operational details with broader compliance goals.
Days 1–2: Off-Site Documentation Review
The team conducted a remote evaluation of SOPs, facility layouts, training records, and quality documentation. This phase identified potential risk areas, informed targeted audit questions, and optimized the effectiveness of the on-site review.
Days 3–5: On-Site Walkthroughs & Stakeholder Engagement
Brevitas facilitated structured walkthroughs of manufacturing and support areas, live evidence reviews, and working sessions with cross-functional stakeholders.
- Workshops created space for open dialogue, allowing team members to “see the forest for the trees” and understand how everyday tasks connect to regulatory expectations.
- Observations aligned with regulatory expectations for CGT facilities emphasized batch record traceability, aseptic techniques, in-process controls, and data integrity.
The assessment delivered both a system-level and floor-level view of GMP maturity, offering a clear roadmap to regulatory alignment and a successful facility launch.
Results Achieved
The audit-readiness assessment provided immediate value and long-term benefit to the client’s operational and compliance strategy:
- Prioritized Risk Remediation: Identified actionable gaps and improvement opportunities, empowering internal teams to prioritize corrective actions based on risk and regulatory impact.
- Cross-Functional Alignment: Facilitated productive discussions across QA, QC, manufacturing, and facilities teams—ensuring shared understanding of GMP expectations in a CGT environment.
- Audit-Ready Documentation: Delivered a structured mock audit report outlining observations, risk categorizations, and practical remediation steps—enabling focused planning and confident regulatory engagement.
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