On 4th September, Nemera received from the German Government Drug Administration (Government Presidium, Tübingen) the pharmaceutical drug manufacturing authorization according to §13 AMG (German Drug &Medicinal Product Law) at its Neuenburg manufacturing facility in Germany.
The certification gives the manufacturing plant the approval to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for autoinjectors.
This approval reflects Nemera’s commitment to quality in developing and manufacturing drug delivery devices.
The Authorization is an important achievement. It confirms that Nemera meets the highest standards required to ensure the manufacturing and testing of the above-mentioned drug, as well as medicinal and medical products. The pharmaceutical drug manufacturing certification is a required regulatory step, in order to allow Nemera to provide a complete set of services and additional support, for the development and manufacturing of pharmaceutical combination products and drug delivery devices to our customers.
“Achieving this pharmaceutical drug manufacturing approval is highlighting our commitment to ensure the safety of our drug delivery devices for the benefit of patients. It is also the confirmation that our quality systems and processes are meeting consistently regulatory requirements and patient expectations,” Christian Meusinger,
quality VP of Nemera, said in prepared remarks.
Neuenburg plant has been manufacturing high quality products since 1953. With more than 20,000 sqm of built up area, the plant has Class 8 clean rooms and more than 400 employees, to guarantee a 7/7 and 24h/24 production. Neunburg plant produces billions of Injection molded parts and assembled devices every year.
Neuenburg quality management key achievements are:
- Short reaction times
- Detailed and comprehensive root cause analysis
- Elimination of quality problems
- Reduction of scrap rates
- Elimination of inefficiencies