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Quality

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
Two scientists wearing PPE and looking at equipment

Ongoing analysis and testing

  • Ongoing cGMP training & development
  • Focus on any-time-audit readiness
  • Testing and release of raw materials, packing materials, in-process samples, intermediates and APIs
  • Dedicated areas for wet analysis and instrumentation (HPLC & GC – powered by Waters Empower3 networking system)
  • Qualification, Calibration and Maintenance of analytical equipment as per schedule
  • Stability testing as per ICH guidelines that covers Accelerated, Long term, Intermediate and Zone IVB
  • All instruments comply with 21 CFR Part 11 regulatory requirement
  • All stand alone systems connected to server for data storage and retrieval

Going forward a digital QMS system will be implemented across our sites.