our quality system meets the cgmp requirements of leading regulatory bodies
quality comes first
As a biopharmaceutical manufacturer with more than 30 years of experience, we are keenly aware of our responsibility to patients and ensure the highest standards of quality in biopharmaceutical production.
Our Quality Management System is set up according to international standards (EU- and US-GMP and ICH guidelines), it is based on quality risk management with the principal of continuous improvement. Quality is an integral part of our daily project work: when starting with implementation of your project we consider already the needs to manufacture according to GMP for early clinical phases up to commercialization. It is the Quality Management System by which we assure to deliver the quality needed for your project with sufficient flexibility for product specific adaptations and to meet regulatory expectations throughout the life-cycle of your product.
All our sites have the respective GMP-certification from the local authorities. Our long history of inspections by international bodies is listed below, numerous audits by our customers are part of our daily business.
We care about people and patient´s health. It is our quality commitment to deliver safe and valuable products at the highest quality to our customers and, ultimately, the patients.
Our Quality Policy is applied at all levels. It is part of the organisational culture and translated within the organization into internal standards which are regularly communicated and trained to assure they are understood. Each individual employee is committed to our quality culture and our Management Team is accountable for regular review and quality-conscious decisions.
Our Quality System not only fulfills the regulatory requirements, which is proven by our track record. We also always strife for process optimization and state-of-the-art technologies. Throughout our organization we apply risk management tools and enforce digitalization to continuously improve our processes and ensure data integrity.
Rigorous quality measures for all product-related activities are defined for the product life cycle – starting from development up to commercial GMP manufacture.
We believe in fostering the experience and expertise of everybody involved that’s why we implemented a speak-up culture internally and quick turnaround of potential challenges with our partners.
A transparent workflow, trustful and open communication as well as collaboration with our people and with our customers ensures continuity of our world class GMP-compliant CDMO services.
Audit History by Regulatory Agencies and Clients
For every customer project we have an in-house quality assurance expert of Richter-Helm BioLogics assigned to the project team and designated QPs on site that perform release of the Drug Substance batches based on our batch record review procedures.