
The Quality Area is divided into
Quality Control and
Quality Assurance. Both departments are composed of teams of duly qualified staff with
high levels of technical training.
Both areas are part of Farmasierra´s
Quality System, required as a primary objective in the organisation´s strategy.
The
Quality Control Department is responsible for confirming the quality of manufactured products, raw materials (active ingredients, excipients and packaging materials) and intermediate and finished products and testing stability until the expiry date.
The Quality Control laboratory conducts physical, chemical, technical-medicinal and microbiological trials and oversees the controls of production staff processes. It also conducts
samplings of raw and processed materials and the qualification of suppliers in order to achieve an optimal level of quality in the materials purchasing process.
Quality Assurance is responsible for manufacturing processes validation, cleaning processes, GMP training programmes, qualification of equipment and systems, external client and health authorities audits, self-inspections, the CAPA (Corrective Actions and Preventive Actions) programme monitoring, claims management and the coordination and monitoring of required documentation used in manufacturing plants.
Grupo Farmasierra is governed by a strict quality system