QUALITY
OUR PRODUCTS CONTRIBUTE TO IMPROVING PEOPLE’S HEALTH AND HAVE MAXIMUM SAFETY GUARANTEES
Our production plant in Martorelles (Barcelona) has a Quality Management System (QMS) based on compliance with the medicine quality and safety guarantee standards in all processes, from the production (GMP and Law 29/2006, of 26 July, on Guarantees and Rational Use of Medicines) to the distribution of medicines for human use (GDP and 2013/C 343/01).
OUR PHARMACEUTICAL QUALITY POLICY IS BASED ON:
• Establishing, executing and maintaining a Quality System that satisfies the needs of patients, health professionals, regulatory authorities and clients.
• Process and activity control that ensures the suitability and quality of the products.
• Promoting technical knowledge and the evaluation of the quality risk analysis to facilitate the achievement of objectives.
WE BASE OUR QMS ON THE GOOD MANUFACTURING PRACTICES OF THE EUROPEAN UNION (GMP) AND OF THE U.S. ADMINISTRATION (21 CFR), IN ADDITION TO OTHER EQUIVALENT GUIDELINES AND REGULATIONS, SUCH AS THE ICH, EMEA GUIDELINES AND GUIDANCE FOR INDUSTRY (FDA)
MAIN SYSTEMS AND FUNCTIONS OF THE QMS
Starting and packaging material system
Product release system
Control of operations under contract
Personnel training
Deviations, corrective action and preventive action (CAPA) system
Change management system
Analytical control laboratory
Validation, qualifications and transfers
Quality audit system
Documentation system
Returns, claims and withdrawals of medicines
Product quality and process monitoring system
THE COMPANY MANAGEMENT PARTICIPATES IN THE DESIGN, IMPLEMENTATION AND MONITORING OF THE QMS SYSTEM, PROMOTING QUALITY CULTURE AND CONTINUOUS IMPROVEMENT, ASSESSING THE RESULTS OBTAINED IN AGREEMENT WITH THE ESTABLISHED OBJECTIVES, AND AUTHORISING THE HUMAN AND MATERIAL RESOURCES REQUIRED TO ATTAIN THE ESTABLISHED OBJECTIVES
OUR PRODUCTION PLANT HAS THE FOLLOWING CERTIFICATIONS:
- GOOD MANUFACTURING PRACTICES EUROPEAN UNION (GMP). Generalitat de Catalunya and Spanish Agency of Medicines and Medical Devices. 2015.
- FOOD & DRUG ADMINISTRATION UNITED STATES (FDA). 2017.
- GOOD DISTRIBUTION PRACTICES EUROPEAN UNION (GDP). Generalitat de Catalunya. 2016.
- SAUDI FOOD AND DRUG AUTHORITY (SFDA). 2013.