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Quality and Compliance

Ensuring quality, safety and reliability from innovation to industrial manufacturing

Home/ Quality and Compliance

Quality Management

At BRAINBiocatalysts, quality is embedded throughout the entire project and product lifecycle. From early-stage research and development to industrial manufacturing, our quality systems, global policies and experienced teams ensure reliable execution, regulatory compliance and successful delivery.

Global Standards

One framework across all BRAINBiocatalysts locations

Our global policies establish a consistent foundation for quality, safety and environmental responsibility across all sites.

Quality & Food Safety

Ensuring product quality, customer satisfaction and food safety through structured quality systems and continuous improvement.

Health & Safety

Creating safe working environments through risk-based management and a strong safety culture.

Environmental Responsibility

Reducing environmental impact and integrating sustainable practices into our operations.

Quality Management in Research & Development

Enabling innovation through structured quality processes

Our scientists are supported by dedicated Quality Management & Process Transfer teams and a comprehensive framework of Standard Operating Procedures (SOPs), ensuring compliance, documentation integrity and efficient progression from discovery to industrial implementation.

Risk Assessment & Pre-Mortem Planning

Every project starts with a structured risk assessment and expert pre-mortem review to proactively identify potential technical, operational and regulatory challenges.

Supplier & Raw Material Qualification

Suppliers and raw materials are evaluated for quality, regulatory suitability and availability at future production scale, supporting successful scale-up and commercialization.

Documentation & Process Transfer

Project-specific methods, processes and results are documented to ensure reproducibility and enable seamless technology transfer to customers, manufacturing operations or external CDMOs.

Quality Management in Industrial Manufacturing

Delivering consistent quality at commercial scale

Our manufacturing sites operate under established quality and food safety systems designed to ensure product consistency, traceability and regulatory compliance.

Process Control & Quality Assurance

Validated processes, defined controls and quality monitoring support reliable manufacturing performance.

Traceability & Documentation

Our systems provide full traceability throughout our supply chain and are embedded in our integrated management system. Comprehensive documentation provides transparency and supports product integrity throughout production.

Continuous Improvement

Our integrated management system drives regular reviews, audits and performance monitoring to drive operational excellence.

Certifications & Industry Engagement

Demonstrating compliance and contributing to industry best practice

Site Certifications

Our sites maintain certifications relevant to their activities and markets, demonstrating compliance with recognized international standards.

Cardiff - Certified Manufacturing Excellence

FSSC 22000
ISO 9001
ISO 14001
ISO 45001
Sedex Member

Nieuwkuijk - Certified Manufacturing & Sustainable Sourcing

FSSC 22000
RSPO

Tampa - Certified Manufacturing

FSSC 22000 (in progress / upcoming)

Zwingenberg - Quality-Driven Research & Development

Operates under the global BRAINBiocatalysts Quality Management System
Dedicated Quality Management & Process Transfer team
Risk assessment and technology transfer framework

Industry Memberships

We actively participate in leading industry / biotech associations, including:

AMFEP
Enzyme Technical Association, ETA
Cluster Industrielle Biotechnologie e.V. (CLIB)
BIO Deutschland e.V.
DECHEMA, Gesellschaft für Chemische Technik und Biotechnologie e.V.

These memberships help us contribute to industry best practices, scientific exchange and regulatory developments.

Our Commitment

Quality, food safety, environmental, health and safety are more than compliance requirements, they are considerations that are built into our working practices. They are the foundation that connects innovation, development and manufacturing - helping our organizations and customers to bring successful products to market with confidence.