Quality
At Gedeon Richter robust quality management systems provides the framework for all development and production activities.
With our strong quality mindset and a successful track record of regulatory authority and client audits, we are able to provide the best service for your global needs.
Services
- On site quality assurance (QA)/Release by our qualified person in full compliance with GxP rules and authority requirements of all highly regulated markets
- Full on-site quality control (QC) testing of our products, processes and systems is performed on-site, using state-of-the-art laboratory equipment. Our dedicated and qualified professional team is trained and operates in accordance with cGMP and relevant ICH guidelines, delivering results to the highest quality standards.
- Stability testing/storage in-house, according to customer and authority specifications.
- Microbial and environmental monitoring services are available on-site.
- All key utility systems have backup services available 24/7.
- Broad experience in quality audits from various regulatory authorities and client audits.
Quality control capabilities
- QC supports both DS and DP operations
- Bioassay Lab
- In Process (IPC) Labs
- Water monitoring Lab
- Microbial and hygiene Labs
- Bioanalytical Lab
Authority qualifications
- Registered with the Hungarian authority (member of EMA)
- GMP systems based on the Richter corporate Quality system
Current licenses
- GMP certificate number (EudraGMP):60981-7-2017
- Debrecen based QP release available
2012
2013
2014
2015
2016
2017
2018
Inspection History
Domestic authority
International authorities
Drug product site
National Institute for Quality- and Organizational Development in Healthcare and Medicines /National Institute of Pharmacy/
Drug product site + Microbial Laboratory
National Institute of Pharmacy and Nutrition
Drug product site
National Institute of Pharmacy and Nutrition
Quality control laboratory of the Drug product site
National Institute of Pharmacy and Nutrition