Nowadays, customers take the highest quality standards for products and processes as a given. Rottendorf’s management team has committed to act accordingly. Our Quality Unit enables us to maintain our high-quality level by applying a standardized quality management system and through regulatory support during all phases of the product life cycle. In addition, regulatory compliance, continuous improvement of all quality systems, and batch release are further tasks of the Quality Unit.
At Rottendorf Pharma we understand the increasing complexity of regulatory requirements. Through our experienced Quality Assurance team we offer all required functions to always achieve full GMP compliance:
Rottendorf Pharma provides all the analytical capabilities you need for outsourced manufacture and development of solid oral dosage forms. To fulfill our commitment as a full-service contract development and manufacturing organization, we support a large analytical department staffed with experts to meet your needs for outsourcing.
Dr. Christian Gausepohl
Senior Director Quality Unit
Release analysis of starting materials
Validation of new and existing methods
Analytics supporting development
Analysis of stability studies
Transfer of analytical methods
Development of new analytical methods
Release analysis of finished products
Performance of stability studies
Optimization of existing analytical methods
The concept of the qualified person according to EU regulations is different from regulatory aspects in the US or in any other state outside of the European Union. The personal responsibility and liability of the QP is a very specific requirement. Each Qualified Person needs to be registered with and appointed or approved by the competent authority of the EU member state in which he or she is operating. Not only the pharmaceutical company for which he or she is acting, but also the registered qualified person themselves is responsible for his or her duties.
Qualified Person, Quality Unit
To enable the QP taking over these responsibilities he or she is directly involved in all quality-related decisions for products and batches including upcoming changes. In-depth knowledge of products, processes, systems and procedures along with experience are keys in making adequate and effective decisions with regard to products, customers and patients. Personal qualification with regard to the legal requirements is a starting point but needs to be continuously expanded with day-to-day operational experience, process understanding, and regulatory knowledge.
The QP at Rottendorf Pharma GmbH as a multinationally operating CDMO also has to make sure that all customers' quality considerations are respected, as defined in the approved Quality Agreements and internal quality procedures – especially against the background of the different country requirements. For that reason he or she is also directly involved in establishing Quality Agreements and maintaining the agreed status.
Total Process Ownership (TPO) as our company philosophy is also applied to the QP services. The QP contributes in providing optimal service for our customer by bringing in his or her competence, expertise and experience.