Clients consider a highest quality standard of all product and processes as given. Rottendorf’s management has fully committed to deliver correspondingly. Our Quality Unit enables to maintain the quality standard by applying a standardized quality management system and by giving regulatory support in all lifecycle phases of a product. Furthermore regulatory compliance, continuous improvement of all quality systems and batch release are important tasks covered by the Quality Unit.
achieving full GMP compliance
At Rottendorf Pharma we understand the increasingly complex regulatory requirements. Through our experienced Quality Assurance team we offer all required functions to always achieve full GMP compliance:
Regulatory support service
Supplier & contractor qualification
Regulatory inspections every year
Annual product quality review
Qualified Person release
Regulatory support service
Cleaning validation studies
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, Rottendorf supports a large analytical department staffed with experts to meet your needs for outsourced:
"To fulfill our commitment as a full-service contract development and manufacturing organization, Rottendorf supports a large analytical department staffed with experts to meet your needs for outsourced."
Release analysis of starting materials
Analysis of stability studies
Release analysis of finished products
Validation of new and existing methods
Transfer of analytical methods
Performance of stability studies
Analytics supporting development
Development of new analytical methods
Optimization of existing analytical methods
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, appointed or approved by the competent authority of the EU member state in which he or she is operating. Therefore not only the pharmaceutical company for which he or she is acting, but also the registered qualified person is personally responsible for his or her duties.
„For Rottendorf Pharma GmbH the QP function is an integral function within the Quality systems. This means the QP is an integral part of the manufacturing license, the person is personally approved by the District Government Muenster and is focussing 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 and experience are keys to adequate and effective decisions with regard to products, customer and patients. Personal qualification with regard to the legal requirements is one thing to start from but needs to be continuously expanded with day to day operational experience, process understanding and regulatory knowledge.
- Release of commercial batches and clinical trial batches using one QMS
- Release for shipment vs. release to market
- Release of medicinal products and test products on to the market in adherence to the Regulations of § 16, subsections 1 to 6 of the AMWHV and for imported medicinal products to the regulations of § 17, subsections 1 to 3 of the AMWHV.
- Batch certification according to EU-GMP-Guide Annex 16
- EU-release for imported drug products
- EMA QP declaration on APIs
- Auditing of API manufacturers for regulatory purposes
- Ensuring that retention samples are stored from each produced batch of a finished medicine in accordance with the provisions of § 18, subsection 1 of the AMWI-IV as well as from each batch of starting materials used for the production of medicines in accordance with the provisions of § 18, subsection 2 of the AMWHV.
- Ensuring that enough samples are stored from all testing materials and their labels and printed packaging materials in accordance with the provisions of § 18, subsection 3 of the AMWHV.
- Controlling of the fulfillment of the requirements of subsection 8, enclosure 16 to the EU GMP Guidelines:
- Ensuring that all papers confirming the compliance of each batch with the regulations of the AMG and the AMWHV are recorded in a consecutive register
- Ensuring that contracts have been concluded with contract manufacturers and contract laboratories
- Ensuring that a QM system has been established and is being implemented at Rottendorf Pharma GmbH
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. Therefore 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 for the services provided by the QP at Rottendorf Pharma. The QP contributes in providing optimal service for our customer by bringing in his or her competence, expertise and experience.