Quality
The quality assurance system is based on risk management of technical systems and production sites, qualification of installations adapted to our activity, process control, cleaning procedures and analytical methods, monitoring of indicators, traceability.
The quality department is independent of production.
The Quality Assurance department is responsible for:
- Process control: each critical step of the product life cycle is controlled: choice of raw materials, suppliers, production, cleaning, filling and packaging
- Control of batch records and registrations
- Release of finished products
- Control of non-conformities and deviations
- Approval of suppliers
- Internal audits
- Customer complaints
- Customer specifications
Each of our two production sites is equipped with a control laboratory with experienced chemists. The Quality Control department is in charge of:
- Batch analysis according to international (Ph.Eur., ACS, ISO, USP, etc.), e
xternal or internal methods - Release of raw materials
- Extension of raw materials
- Qualification and calibration of laboratory equipment
- Archiving of laboratory documentation
- Management of reference materials
- The sample library
- OOS investigation
- Implementation of validity test protocols
- Creation of analysis certificates