Aragen has implemented a comprehensive Quality Management System (QMS) meticulously designed to align with industry standards at every phase of the product lifecycle. This phase-specific approach enables precise compliance with regulatory requirements from early clinical stages to late-stage studies.
We ensure our operations meet the highest standards by strictly adhering to comprehensive global regulatory requirements and maintaining robust quality management practices. This includes deviation management, change control, CAPA (Corrective and Preventive Actions), and investigation processes.
- Global regulatory compliance: Follows ICH, WHO, 21 CFR, ISO, and OECD GLP standards.
- Quality assurance: Aligns with ISPE guidelines and US-FDA approved facilities.
Process Control & Digitization
Our facility uses advanced technologies for precise control and digitization:
- Building management system: Monitors clean room parameters such as temperature, relative humidity (RH), and differential pressure.
- Centralized process control: Integrates equipment and systems for reporting and trend analysis.
- Remote monitoring: Automated alerts for compliance.
- Paperless operations: Integration with SAP, MES, e-BMR, e-Log and process analytical technologies (RAMAN, and online variable path spectroscopy).
Quality Control and Testing Services
Our Quality Assurance team ensures strict adherence to standard operating procedures (SOPs), batch records, sampling plans, and shipping protocols.
- Raw Material Testing & Release: Utilizes advanced equipment for pharmacopeial testing.
- Analytical Method Transfer/Validations: Ensures methods comply with USP and ICH standards.
- Batch Testing and Release: Supports in-process testing and batch release via LIMS.
- Stability Studies: Establishes shelf-life according to ICH guidelines.
- Reference Standard Qualification: Qualifies standards and biosimilars per ICH Q6B and Q7.
- Microbiological Testing: Assures product safety and compliance by detecting and controlling microbial contamination.
Comprehensive Regulatory Support
- Lifecycle solutions: Includes biosimilarity assessments, process verification, resin recycling, and stability studies.
- Regulatory submissions & support: Manages global submissions (IND/IMPD, BLA/MAA, NDA) and provides CMC support.