Implementation of highest quality standards and profound experience in the field of pharmaceutical technology are imperative for a safe and efficient production of pharmaceuticals.
A quality management system, continuously monitored and improved, is the key factor to constant high product quality.
All processes at Richter Pharma AG, from selection of the raw material suppliers to any production flow and packaging are subject to stringent quality controls.
The development, production and storage of our products conforms with highest international GMP standards for manufacture of pharmaceutical products.
Every step of our production process is validated, our production facilities are qualified regularly.
For veterinary pharmaceuticals we offer:
- GMP-standard production, costumised manufacture of small batches
- Filling and packaging
- Package changing
- Quality control
- Analysis of stability
- GMP standard storage
Use of validated ERP-software from raw material to finished product.
Focus on Manufacturing
The area of expertise of Richter Pharma AG is the manufacturing of sterile and none sterile solutions. Our main focus is on diluted solutions for injection.
Semi solid forms like ointments and gels complete our portfolio.
GMP-standard production facilities and air-conditioned production halls with surround monitoring in all areas guarantee highest quality.
The development, manufacture and storage of products are carried out according to GMP and ISO guidelines.
For sterile liquids in vials from 10 ml to 250 ml we use a state of the art filling and packaging line.
Automatic filling is followed by semi-automatic packaging (labeling and packing in a carton box with SPC-leaflet).
Solutions, Ointments and Gels
For solutions and gels up to 1000 l scheduled quantity, as well as for ointments with scheduled quantity up to 250 l a semi-automatic filling and packaging line is used.
All our filling lines, as well as our state of the art clean-room technology conform with GMP standards.
- Continuous temperature monitoring with 24 hour emergency support
- State of the art tagging and identification of stored products with validated warehouse management software and batch oriented material management
- Validated electronically supported stock management
- Storage according to Ph. Eur. at 25°C
- Refrigerated storage according to Ph. Eur. at 2-8°C
Quality control at Richter Pharma AG is based on state of the art analytical methods. Inspection of raw material and finished products, method development as well as method amendment including all required validations are done routinely. We also have qualified climate chambers for the testing of stability according to the relevant guidelines.
HPLC, IR, NIR, AAS, UV/VIS are the available analytical methods according to GMP standards.
Focus on Quality
Safe and efficient manufacture of pharmaceutical compounds needs the strict implementation of highest quality standards and profound experience. Permanent improvement of our quality management system guarantees constant high quality of our products.
At Richter Pharma AG every step of our production is supervised-from inspection of every single raw material through the whole production process to the approval of the finished product.
Every single step during manufacturing is validated, production facilities are getting qualified on a regular basis.