Quality is Our Unwavering Commitment
Quality is not a department at INVIVO; it is our core identity. We recognise that patients entrust us with their health, and we honour that trust by embedding the highest global standards into every medicinal unit we produce and every dose we deliver. We don't just meet expectations—we set the benchmark for excellence.
We operate a sophisticated, harmonised quality ecosystem designed for total oversight with proactive benefit-risk evaluation.
Systematic risk-based framework ensuring consistency, efficiency, and global pharmaceutical compliance.
Driven by audits, self-inspections, KPI tracking, and global industry intelligence to ensure dynamic quality excellence.
Our QMS is architected on the rigorous principles of the International Council for Harmonisation (ICH Q10). This systematic, risk-based framework ensures that product safety and quality are achieved with absolute consistency and efficiency.
The INVIVO Quality Manual serves as our constitutional document, aligning our global functions, manufacturing sites, and suppliers with the mandates of the FDA, EMA, ISO 9001:2015, and ICH.
To ensure total objectivity, our Head of Quality leads an independent organisation reporting directly to Senior Management. This autonomy guarantees that quality remains the final authority in every decision.
We maintain exhaustive in-house testing specifications for every raw material and finished product. In strict accordance with GMP guidelines, no product enters the market without full compliance.
Real-time monitoring during production ensuring absolute consistency and safety.
Ensuring product efficacy remains stable and reliable throughout its lifecycle.
Adherence to the highest global analytical and regulatory standards.
At INVIVO, compliance is the baseline, but excellence is our target. Our robust, independent audit ecosystem is designed to safeguard quality and safety across the entire medicinal lifecycle.
This unified global framework ensures every manufacturing site, internal function, and strategic supplier operates with absolute precision.
We employ a data-driven, risk-based approach to oversight. Audit frequency and depth are defined by risk assessments and operational criticality, ensuring full lifecycle surveillance.
Every audit is conducted by a team of certified lead auditors who bring deep industry expertise to every evaluation.
Audit findings are reviewed and approved through an autonomous quality channel to ensure total objectivity.
Every auditee must submit a comprehensive Corrective and Preventive Action (CAPA) plan, fully implemented before closure.
Our annual audit strategy is a dynamic framework, continuously evolving to address emerging risks and regulatory changes.
INVIVO views regulatory inspections as an opportunity to demonstrate operational mastery. We maintain a transparent and collaborative relationship with global health authorities to ensure the highest international benchmarks.
We maintain a “zero-blind-spot” policy. Any deviation or process failure triggers immediate and thorough investigations to identify and eliminate root causes.
We do not wait for external inquiries. In case of significant deviation, we act immediately, implement corrective measures, and proactively notify health authorities.
Empowering Excellence: Training & Human Capital Mastery
At INVIVO, our greatest asset is the collective expertise of our people. We maintain a sophisticated, multi-tiered quality and safety training architecture that ensures every associate—from the laboratory to the boardroom—is equipped to uphold uncompromising standards.
Our pedagogical framework is subject to regular, rigorous audits to ensure it remains aligned with global pharmaceutical excellence.
Every member involved in technical operations undergoes comprehensive GxP onboarding and continuous education. Our “Quality-First” curriculum is designed to build deep operational excellence across all levels.
Advanced protocols for product quality monitoring and adverse event reporting systems.
Strict governance over data accuracy, record-keeping, and traceable documentation practices.
Clear escalation pathways ensuring transparency, accountability, and rapid issue resolution.
For our teams embedded in manufacturing, supply, and distribution, training is an evolving journey. We mandate high-frequency recertification in specialised technical areas to ensure precision in high-stakes pharmaceutical production.
Our “Tribe”, including all strategic contractors, operates under continuous capability enhancement frameworks.
Maintaining the highest levels of biological safety and contamination control in controlled environments.
Empowering teams to perform root-cause analysis with forensic accuracy and regulatory compliance.
Ensuring seamless quality integration across complex manufacturing and supply chain interfaces.
We believe that a supply chain is only as strong as its most distal link. Therefore, we extend our rigorous training expectations to every third-party partner providing GxP-standard materials or services.
We require all suppliers to maintain independent Quality Assurance departments and formal training programs aligned with ICH (International Council for Harmonisation) and PIC/S mandates.
Continuous training is a non-negotiable requirement under global GMP regulations. We don’t just ask for compliance — we verify it.
Through routine audits, we assess third-party training effectiveness, ensuring full regulatory adherence across all partners and processes.
Third-Party Governance Excellence Framework
At INVIVO, our commitment to quality extends far beyond our own walls. We maintain a rigorous, multi-layered oversight framework to ensure that every partner operates with precision, ethics, and regulatory compliance.
We build a network of verified excellence. All suppliers must maintain active GMP and GDP certification, ensuring regulatory alignment across the entire ecosystem.
Direct partners are held to the highest regulatory benchmarks with strict quality validation and compliance audits.
Tier 1 suppliers must enforce equivalent compliance standards across Tier 2 providers, ensuring end-to-end quality propagation.
Complexity is never an excuse for quality lapse. INVIVO enforces strict GMP regulations across all outsourced activities, including Tier 2 and beyond suppliers.
Clearly defined Quality Agreements eliminate ambiguity and ensure full GMP responsibility alignment with Marketing Authorisation requirements.
Even indirect suppliers must meet INVIVO standards through structured operational and legal compliance frameworks.
Through Rigorous Auditing Excellence
Our oversight is validated by one of the industry's most aggressive audit programs. We do not rely on paperwork alone; we verify excellence directly on the ground.
INVIVO conducts continuous audits covering both Tier-1 and critical Tier-2 partners, ensuring end-to-end compliance visibility.
Every audit evaluates facilities, quality management systems, and operational processes with full regulatory depth and precision.
Our audit framework spans manufacturing sites, suppliers, and distribution networks to maintain consistent global standards.