Quality Excellence

Quality is one of the core pillars of our organization and a fundamental part of our identity as CDMO. We are committed to deliver services that consistently meet customers expectations in terms of quality and regulatory compliance. As a specialized partner in particle engineering, our role requires constant focus on patient safety and product performance. Micro-Macinazione Quality Management System is built on many years of hands-on experience within the pharmaceutical industry, reflecting deep regulatory knowledge and a thorough understanding of GMP manufacturing environments.

Our commitment to quality enables long-term partnerships built on trust, transparency, and consistent performance.

Our Quality Management System is designed to support the full lifecycle of micronized pharmaceutical products, from development to commercial manufacturing. Our Quality Assurance and Quality Control teams work in close collaboration with operations to ensure full compliance and process robustness. Micro-Macinazione has a dedicated QA oversite team maintains an active and continuous presence on the shopfloor, actively supporting daily activities, promoting right-first-time execution, and ensuring GMP principles are applied.

We recognize that data integrity is essential to product quality, regulatory compliance, and customer trust, all quality-related data are managed in accordance with ALCOA+ principles.

Our facility operates in compliance with EU GMP guidelines and is subject to regular regulatory inspections by competent authorities. In addition, we constantly receive customer audits, supporting transparency and demonstrating the robustness of our quality systems. Compliance is a continuous process, supported by ongoing training, internal audits, and management review, ensuring sustained alignment with regulatory expectations and industry standards.

For our processes, we implement containment strategies to ensure operator safety, environmental protection and prevention of cross-contamination by integrating sustainable practices into our Quality System. Micro-Macinazione supports safe manufacturing processes while meeting environmental and occupational safety expectation.