Pharmaceutical and medtech manufacturers operate under strict global GMP requirements. Early and ongoing oversight is essential to prevent compliance failures, audit findings and regulatory actions. Our GMP Risk & Compliance Oversight service provides structured, evidence-based assessment across sterile, non-sterile, ATMP, oral solid dose and cosmetics operations. We help you identify risks before they escalate and ensure your systems, processes and controls meet EU GMP, FDA CFR, Annex 1 and ISO expectations.

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Comprehensive GMP Compliance Assessments

We conduct detailed GMP compliance assessments that benchmark your facility and quality systems against regulatory standards.
Our assessments cover:
• Sterile and aseptic manufacturing environments
• Non-sterile production and microbiological risk areas
• ATMP and cell therapy operations
• Oral solid dose (OSD) facilities
• Cosmetics and personal care regulated environments

Each assessment evaluates procedural controls, documentation readiness, contamination risks, personnel practices, utilities, cleaning systems, material flows and environmental controls.

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Annex 1 and Contamination-Related Risk Identification

Contamination prevention is a critical component of modern GMP oversight. We apply risk-based tools to identify:
• Microbial and particulate contamination risks
• Operator-driven contamination pathways
• Weak points in cleaning and sanitisation practices
• Environmental monitoring gaps
• Failures in gowning, material transfer and segregation
• Utilities and support systems that contribute to contamination events

Our risk identification aligns directly with the latest EU GMP Annex 1 requirements and current expectations for contamination control strategies across all dosage forms.

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GMP Audit Preparation and Independent Audit Support

We help clients prepare for inspections and internal audits by identifying compliance gaps early.
Support includes:
• Pre-audit compliance reviews
• Mock GMP audits
• Documentation sampling and traceability checks
• Regulatory referencing to EU GMP, FDA 21 CFR Parts 210/211 and Annex 1
• Action plans to close gaps before authority or customer audits

This ensures your facility, quality systems and records are audit-ready and defensible.

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Clear Outcomes for Manufacturing and Quality Leaders

• Reduced regulatory and compliance risk
• Stronger inspection readiness
• Earlier identification of Annex 1-related issues
• Improved contamination control across all facility types
• Evidence-based decision-making for remediation and improvements

Our service strengthens compliance across the full manufacturing lifecycle, helping companies operate with confidence in complex GMP-regulated environments.