Quality

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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).

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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.

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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)

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MAIN SYSTEMS AND FUNCTIONS OF THE QMS

  • Starting and packaging material system

  • Analytical control laboratory

  • Product release system

  • Validation, qualifications and transfers

  • Control of operations under contract

  • Quality audit system

  • Personnel training

  • Documentation system

  • Deviations, corrective action and preventive action (CAPA) system

  • Returns, claims and withdrawals of medicines

  • Change management system

  • Product quality and process monitoring system

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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

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OUR PRODUCTION PLANT HAS THE FOLLOWING CERTIFICATIONS:

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  • GOOD MANUFACTURING PRACTICES EUROPEAN UNION (GMP). Generalitat de Catalunya and Spanish Agency of Medicines and Medical Devices. 2015.

  • GOOD DISTRIBUTION PRACTICES EUROPEAN UNION (GDP).Generalitat de Catalunya. 2016.

  • FOOD & DRUG ADMINISTRATION UNITED STATES (FDA). 2017.

  • SAUDI FOOD AND DRUG AUTHORITY (SFDA). 2013.

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