GMP (Good Manufacturing Practice) means good practices in the manufacture of medicinal products. The GMP rules are national and international rules which codify requirements in relation to things such as hygiene, facilities, equipment, documentation and traceability. Quality assurance plays a central role in pharmaceutical manufacturing as deviations in quality could have a direct impact on the health of a patient. Our employees receive regular training and professional development in GMP guidelines.
Röchling Medical Brensbach and Röchling Medical Neuhaus carry out their manufacturing in strict adherence to these guidelines.
What does GMP mean for our customers?
We can provide guarantees on request, e.g. free from DNA residues or pyrogens. Thanks to our processes and our level of automation we are also able to develop production processes on demand to manufacture products that are 100 % free of any human touch. For projects with specific requirements, we are also in a position to set up production processes with higher cleanroom specifications than our standard cleanroom conditions. Feel free to get in touch!
In addition, we can carry out customer-specific checks, enhance documentation and deepen qualification and validation procedures to meet your individual requirements.
Counterfeit protection and traceability are becoming increasingly important in the pharmaceutical industry. European parliament directives 2001/83/EC and 2011/62/EU, and requirements from the FDA set out measures to prevent counterfeit pharmaceuticals entering into the legal supply chain. These guidelines were supplemented by Commission Delegated Regulation (EU) 2016/161 dated October 2, 2015. We work actively with packaging security features that, in line with regulations, are individually identifiable and tamperproof – w are the right partner for you.
Your product is valuable - we will work with you to find the right solution for you!