Production division

• A room dedicated to Steroids
• A separate building dedicated to the treatment of ß-lactamines for veterinary use with 2 production rooms
• Dedicated production rooms
• Independent streams
• A VMP (Validation master plan) defines the qualifications and validations of all the equipment on our site

• Various size and shape specific equipment to adapt to the nature and volume of each batch
• A regular microbiological control is carried out on equipment, production rooms (GMP class D), compressed air and demineralized water systems according to the European Pharmacopoeia

• Regular particle counting is performed on the compressed air system and the HVAC

Qualified equipment

All our equipment are qualified according to the GMP, (production equipment, laboratory equipment …). Qualifications and their regular verification are carried out by our company or by external companies. Qualification reports are prepared for each of the equipments. The details of the qualifications and validations to be carried out on the site are established annually in the VMP (Validation Master Plan). Quality Assurance manages the monitoring of the VMP.

Cleaning validation

After each product campaign, a disassembly of the production equipment and a complete cleaning of the room and equipment is carried out. This is to remove all traces of the product and to avoid any risk of cross-contamination. The disassembly and cleaning phases are detailed in internal procedures.
In order to verify the conformity of the cleaning, a validation of the cleaning is based on the method of the worst cases that has been put in place on our site. Authorized production operators are responsible for performing the cleaning. Laboratory staff is in charge of validating the worst case cleaning. Quality Assurance is in charge of monitoring and validation of the results.