Quality & Certification
Quality Control
Quality Control is an integral part of the quality assurance of the manufacturing process.
Quality Control includes:
• Inspection of incoming materials from suppliers to ensure compliance with standard procedures and materials specifications.
• In-process inspection of all stages of the production processes, as well as batch release analytical and microbiological testing to ensure compliance with product specification.
Performed Tests
A list of performed tests is as follow:
• Bacterial Endotoxin
• Sterility
• Visual examination
• pH
• Osmolality
• Fill volume inspection
• Viscosity
• Quantification of main ingredients
• Detection of allowed limits in certain ingredients
• Extrusion force
Final Inspection
Final inspection is performed after the packaging and labelling stage, whereas the batch record is released to market when all inspections, tests results and records are fully compliant and meet the acceptance criteria.
Manufacturing premises are designed, built, maintained and certified through periodic monitoring and validation, to comply with EUGMP Class 5 clean room.
Dermal fillers and bio-revitalization products based on hyaluronic acid are 93/42/EEC approved and manufacturing is certified according to ISO 9001:2008, ISO13485:2003 and EN/ISO 13485:2012.