Escientia maintains a highly efficient quality management system with emphasis on compliance with regulatory requirements and all quality parameters related to identity, purity, safety and efficacy. Quality assurance is paramount for our operations and ingrained in our philosophy. Some of the procedures and processes we utilise:
- Ensuring superior design and continuous proactive improvement of products and processes
- Providing continuous regulatory and technical training
- Cleaning validation in accordance with PIC/s & EMA guidance
- Analytical method validation is performed according to global standards
- Internal Audits are conducted periodically for all GMP critical area’s as per pre-determined schedules
- Focus on “Quality Metrics Data” in accordance with FDA guidance
The Quality department is independent of manufacturing. The Escientia quality system is created based on ICH Q7 & 21 CFR Part 210 and 211
Data management and processes
- All the data generated at Escientia follow Attributable Legible Contemporaneous Original Accurate (ALCOA) principle to ensure completeness, consistency and accuracy of data
- Data integrity ombudsperson identified with focus on Good Documentation Practice, Data Security and Data Integrity
- All the electronic data generated comply with 21 CFR Part 11 requirements
- Critical process parameters from field instruments, chromatography, data and data from laboratory stand alone system are secured electronically
