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Quality at Primopus

Primopus will maintain 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 will be utilising:

  • 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 performed according to global standards.
  • Internal Audits 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 Primopus quality system is created based on ICH Q7 & 21 CFR Part 210 and 211.

 

Data management and processes

  • All the data generated at Primopus follows the Attributable Legible Contemporaneous Original Accurate (ALCOA+) principle to ensure completeness, consistency, accessibility and accuracy of data.
  • All the electronic data generated comply with 21 CFR Part 11 requirements:
  • Critical process parameters and data from field instruments, chromatography,
    as well as laboratory stand alone systems are secured electronically.

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.