Our factory is composed of 9 completely independent production rooms reserved for API and AA processing.
Each production room is completely autonomous (HVAC, compressed air)
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.
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.