Quality & sustainability management

The pharmaceutical industry prioritizes compliance with current Good Manufacturing Practices (cGMP) to ensure the quality and safety of its products. Our organization is committed to meeting these standards and operates a rigorous qualification and validation of manufacturing and processing systems in accordance with regulatory requirements.

Our processes are certified in accordance with ISO 9001:2015, which guarantees comprehensive quality management. In addition to this certification, we pay attention to the environment and meet the requirements of ISO14001:2015. Furthermore, our sustainability performance is assessed annually by the external sustainability rating EcoVadis by independent third parties.

Our efforts also include adapting the installation and operational qualification (IOQ) processes to the individual needs of our customers, thus ensuring smooth and rapid implementation of the systems in the customer's cGMP-compliant production environment.

We apply the principles of Good Engineering Practice (GEP) and hygienic design and follow GMP-compliant documentation standards, including the ALCOA+ principles, to ensure transparency and traceability. Our approach to risk management follows ICH Q9 guidelines and incorporates life cycle management practices. Our software systems meet the requirements of 21 CFR Part 11 and the GAMP 5 principles, ensuring regulatory compliance and data integrity.

We have a cleanroom in our factory that complies with ISO 14644 standards. This cleanroom is essential for highly sensitive testing as it provides a controlled and representative environment. Our cleanroom meets the requirements of ISO 6 at rest and ISO 7 in operation. 

In this cleanroom, we also offer RNase-free treatment as a service. This service allows our customers to send their single-use components or single-use assemblies to 3CON for treatment. The entire process is documented through a complete batch record. After treatment, a quality control is performed, during which the goods are inspected, approved, and certified by our QC department. If required, the components or assemblies can also be sterilized by us using gamma radiation. This sterilization process is validated according to the worst-case approach in compliance with ISO 11137.

Our integrated approach, combined with our strict regulatory compliance and commitment to continuous improvement, makes 3CON a reliable partner for the provision of first-class pharmaceutical products, equipment and services. Your direct link to 3CON Quality Management: