Quality Management System
Santa Farma places a strong quality mindset at the core of all its processes, conducting its manufacturing and R&D activities in line with GMP and international quality standards, with a focus on human health, reliability, and continuous improvement.
Quality Management System
As Santa Farma Pharmaceuticals Inc., we are committed to ensuring access to safe and effective generic medicines while maintaining the highest standards for human health.
We fully comply with current and applicable quality, manufacturing, distribution, and traceability standards, as well as national and international regulations.
Our Quality Management System is a performance-driven, sustainable, and continuously improving system, fully supported by top management and embraced by all employees. Through a risk-based approach, critical processes are proactively identified, evaluated, and controlled.
By utilizing up-to-date technologies and digital solutions in production and quality processes, efficiency and accuracy are enhanced. In addition to producing high-quality products, flexibility, reliability, and traceability are ensured across manufacturing and supply chain operations to maintain competitiveness in global markets.
Quality Directorate
Our Directorate has adopted a global quality management approach and aims to establish its systems and practices as a recognized standard under the “Santa Farma Quality” brand, led by a highly qualified and experienced team and aligned with legal and international requirements.
The organization is structured with the following departments: Quality Assurance, Quality Control, Microbiological Control, Quality Projects, CMO, and Validation.
Our laboratories, consisting of Quality Control (2,550 m²), Microbiology (266 m²), and six different In-Process Control (IPC) areas located within production zones (totaling 90 m²), cover a total of 2,906 m² under the responsibility of the Quality Directorate. The following core quality control activities are carried out in these laboratories:
- Product/Raw Material Control Laboratory
- Physical/Chemical Analysis Laboratory
- Microbiology Laboratory
- Validation and Stability Studies
- In-Process Control Operations
All activities are conducted using advanced, state-of-the-art equipment in full compliance with cGMP and cGLP requirements. All generated data are securely stored, with data integrity and recovery ensured in accordance with international standards.
Quality Approach from R&D to Manufacturing
Santa Farma R&D Center aims to develop innovative and high value-added products at every stage of the product development lifecycle, while ensuring full compliance with current GMP practices and global quality requirements.
Adopting a human-centric approach, the center prioritizes delivering reliable, accessible, and alternative treatment options for patients.
In this context, all activities are carried out within the framework of the globally recognized Quality by Design (QbD) approach, in alignment with international scientific and regulatory guidelines, including those of the US-FDA, EMA, WHO, and ICH. All relevant updates are continuously integrated into the processes.
Products developed under this approach are transferred to commercial manufacturing processes with the same level of quality and scientific rigor. Technology transfer activities are executed in full alignment with both national and global market expectations.