Quality & Compliance
At Stemmatters, we are dedicated to achieving excellence in every aspect of our work, from innovative product development to cGMP manufacturing. Our mission is to deliver solutions that meet the highest standards of safety, effectiveness, and regulatory compliance.
Quality policy
Stemmatters' quality policy supports the development and manufacturing of a diverse range of products, including raw materials and medicinal products. We strive to enhance our practices continually, ensuring that we exceed customer expectations and comply with evolving regulatory standards.
Our quality policy integrates seamlessly with our teams' roles and responsibilities, enabling us to deliver safe, effective, and reliable solutions.
Key pillars of our quality policy
Quality Management System
Our Quality Management System (QMS) is certified and maintained in accordance with ISO 9001:2015 requirements. Designed to enhance organisational performance, our QMS ensures efficiency, effectiveness, and full alignment with customer needs while adhering to EU GMP Guidelines and ICH Q7 standards. Stemmatters holds a GMP certification and is a manufacturer registered in the EudraGMDP database operated by European Medicines Agency (EMA).
Our QMS encompasses the following areas:
- Quality agreements
- Regulatory inspections
- Partner/customer audits
- Internal audits
- Documentation management
- Risk management
- Supplier qualification
- Process validation
- Facility and equipment qualification
- Complaints and non-conformities management
- Change control management
Quality Assurance (QA) and Quality Control (QC)
Our Quality Assurance (QA) ensures that medicinal products are consistently produced and controlled in accordance with the highest safety and quality standards. QA oversees the maintenance and continuous improvement of our QMS, effectively managing deviations, corrective and preventive actions (CAPAs), controlled documents, and audits. By leveraging Quality by Design (QbD) principles, we proactively identify and mitigate potential challenges, ensuring robust and reproducible quality at every stage of the project. Quality Control (QC) complements QA by conducting rigorous testing and verification processes to ensure that materials and products meet all specified quality and safety standards. QC involves the application of various analytical methods to support the characterisation and quality control of a broad range of products, adhering to applicable standards and normative references. For more details, please visit our Analytical Services page.
By ensuring strict adherence to both QA and QC principles, we guarantee the quality, safety, performance, and efficacy of our customers' products at every stage of the manufacturing process.
Additionally, our Qualified Person (QP) oversees batch certification, ensuring full compliance with current EU Directives for Biological and ATMP products.
Ready to transform your vision into reality?
Get in touch to learn more about our work and how we can collaborate.