Quality Systems: Responsible for establishing, maintaining and continually improving the Quality Management System.
Manufacturing Campus
Quality
With our manufacturing infrastructure compliant with international quality standards and the approvals we have obtained from U.S. and European health authorities, we provide reliable, high-quality manufacturing solutions in both local and international markets.
As one of Türkiye's leading pharmaceutical companies, Sanovel continues to research, develop and manufacture innovative healthcare solutions at its manufacturing facility, which received US FDA approval in both 2018 and 2023. These successful inspections demonstrate our compliance with international quality standards and further strengthen our strategic position in global markets. With manufacturing infrastructure fully aligned with international quality, operational excellence and sustainability standards, we continue to deliver reliable, high-quality manufacturing solutions to partners worldwide.
Our manufacturing facilities, approved by U.S. and European health authorities, operate in accordance with:
ISO 45001
Occupational Health and Safety Management System
ISO 14001
Environmental Management System
ISO 50001
Energy Management System
Quality Assurance
Contract Manufacturing Quality Systems: Ensures that contract manufacturing activities performed for business partners fully comply with applicable quality requirements.
Validation: Responsible for validating facilities, equipment, manufacturing processes and computerized systems to ensure compliance with established quality standards.
In-Process Control (IPC): Monitors manufacturing activities throughout production and coordinates in-process quality controls.
Product Release: Evaluates compliance with all quality requirements prior to batch release and manages final product approval processes.
Quality Control
Incoming Quality Control: Performs testing and documentation review of raw materials, excipients and packaging materials to verify compliance with approved specifications.
Finished Product Quality Control: Tests intermediates and finished products against approved marketing authorization specifications to support batch release decisions.
Stability: Monitors product quality throughout shelf life and evaluates stability study results.
Microbiology: Performs microbiological testing of raw materials, products and manufacturing environments to ensure microbiological compliance.
Contract Manufacturing Projects: Plans analytical activities for contract manufacturing projects while managing method transfer and technical evaluation of analytical results.
Method Validation and Compliance: Conducts analytical method validation, verification and transfer studies while ensuring compliance with current regulatory guidelines.
Operations throughout the Sanovel R&D and Manufacturing Campus are monitored and managed through integrated digital systems, including:
Warehouse Management System (WMS): Provides real-time warehouse management for raw materials, intermediates and finished products while ensuring efficient inventory control.
Quality Management System (QMEX): Manages quality processes including: Deviations, Change Control, Complaints, Corrective and Preventive Actions (CAPA).
BEAM – Business Corporate Asset Management System: Supports the planning, scheduling and monitoring of equipment maintenance, calibration and qualification activities.
E-KT System (Electronic Instructions for Use System): Provides digital management of current Instructions for Use (IFUs) and ensures controlled access by relevant personnel.
PRO Manage Manufacturing Execution & Production Management System: Supports production planning, production monitoring and digital manufacturing operations to improve operational efficiency throughout the manufacturing process.
EMPOWER Empower Chromatography Data System (CDS): A laboratory data management system used to acquire, process and securely manage chromatographic data generated during analytical testing.
Lab Manage Laboratory Management System (LMS): Provides digital planning, management and tracking of laboratory samples, analytical testing and laboratory workflows.
Quality Control Laboratory Equipment
78 High-Performance Liquid Chromatography (HPLC) Systems
8 8 Gas Chromatography (GC) Systems
30 Dissolution Testers
4 UV-Visible Spectrophotometers
2 Atomic Absorption Spectrometers (AAS)
Competent Authority / Country Date Validity
