DE CONTACT OUR BUSINESS COMPETENCE CUSTOMERS DIFFERENTIATORS RESPONSIBILITY INTELLIGENCE CENTER CAREER QUALITY UNIT Standards ensure quality and smooth processes COMPETENCE // QUALITY UNIT 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. QUALITY ASSURANCE Achieving Full GMP Compliance 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: REGULATORY SUPPORT SERVICE REGULATORY INSPECTIONS EVERY YEAR QUALIFIED PERSON RELEASE CLEANING VALIDATION STUDIES SUPPLIER & CONTRACTOR QUALIFICATION ANNUAL PRODUCT QUALITY REVIEW REGULATORY SUPPORT SERVICE QUALITY CONTROL The Integrity of the Product Counts 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. "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 Analysis Release analysis of starting materials Validation Validation of new and existing methods Development Analytics supporting development Analysis Analysis of stability studies Transfer Transfer of analytical methods Methods Development of new analytical methods Analysis Release analysis of finished products Studies Performance of stability studies Methods Optimization of existing analytical methods QUALIFIED PERSON An important integral function 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 "For Rottendorf Pharma GmbH the QP function has a fundamental function within the Quality Systems. The QP is also an integral part of the manufacturing license and is personally approved by the District Government of Muenster, focusing on quality evaluation and release function." "The QP at Rottendorf Pharma GmbH as a multinationally operating CDMO also has to make sure that all customers' related quality aspects are respected as defined in the approved Quality Agreements and internal Quality procedures – especially against the background of the different country requirements." 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 SCOPE OF SERVICES FOR OUR CUSTOMERS IS DEFINED PER INDIVIDUAL QUALITY AGREEMENTS SUCH AS: 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. Privacy Terms Of Use Imprint Jobs Copyright © ROTTENDORF PHARMA 2021. All rights reserved. Site by GLEUSSNER HELBACH DESIGN