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ONE OUT OF TEN EMPLOYEES IS DEDICATED TO QUALITY AT SANTA FARMA

In pharmaceutical industry, competitive advantage is mainly based on quality which can be guaranteed as a result of R&D activities and value added production efforts. In that respect, Santa Farma prioritizes workflow processes related to quality systems by ensuring that one out of 10 employees is assigned in the quality department.

Santa Farma was incorporated as ‘Farma Laboratory’ in 1944. After manufacturing pesticides, cough drops and syrup and other simple but widely used medicines, the company merged with ‘Santa Laboratory’ in 1946. The decision to establish a manufacturing plant in 1953 was followed with the establishment of Santa Farma İlaç Sanayi A.Ş. in 1973.

Zeynep Bodur Korkmaz, Quality Director at Santa Farma, underlines that quality system is among the priorities of the company and says, “This is why one out of every ten employees is assigned in the quality division in the company. We offer our services with a competent team of professionals in our state-of-the-art labs with modern infrastructure and electronic systems that are meant to satisfy cGMP, Legal (TR and EU) and international requirements with respect to quality system management.”

ANALYSES CONDUCTED IN NINE DIFFERENT FIELDS

Korkmaz notes that the quality division is comprised of three departments which are “Quality Assurance, Quality Control and Microbiological Control. These departments are engaged in performing all kinds of starting material, finished or intermediate product analyses in nine different fields comprised of five distinctive in-process controls, three distinctive quality controls and a specific microbiological control.” Korkmaz adds that validated software, QMex, is used for managing all sorts of quality management processes including documentation, change control, customer complaints, deviations, audits, trainings, and corrective and preventive actions.

SANTA FARMA ESTABLISHES AN OTC DIVISION

Ersin Yıldırım, R&D Director at Santa Farma, explains that the R&D centre which is accredited by the Ministry of Industry and Technology performs its operations on a 4-storey building located on around 3 thousand sqm in Dilovası. Yıldırım points out that the R&D centre comprises pharmaceutical technology labs, pharmaceutical-analytical development labs, stability zones, project development, patent & intellectual rights and clinical research offices. Referring to the use of state-of-the-art production and lab equipment in the R&D centre which is compatible with international standards, Yıldırım says, “Our R&D operations are based on the pillars of innovation and distinction. Hence, we do our best to remain a distinguished company through harmonization with the ever changing global dynamics thanks to our dedication to innovation and our vision to grow faster than the market average. The recent transformation supported by our new manufacturing and R&D plant resulted in the establishment of an OTC division at Santa Farma and this will certainly reinforce our position in the market as it will enable us to launch new products through adoption of different business models.”

20 THOUSAND AUTOMATION POINTS

Uğur Çağlayan, Plant Director at Santa Farma, states that Santa Farma uses a building automation system which is compatible with 21CFRPart11. “Our state-of-the-art plant is equipped with 20 thousand automation points including building management system HVAC automation, lighting automation, cooling groups automation, heating and water preparation systems. We manufacture solid, liquid and semi-solid dosage forms in our plant,” Çağlayan says. Çağlayan adds that the plant holds a manufacturing permit issued by Turkish Ministry of Health in addition to the GMP (Good Manufacturing Practices) certification and says, “The EU-GMP (European Union-GMP) certificate which is valid in the entire Europe in addition to many other countries means that our production activities are acknowledged by international authorities.”