High Pressure Liquid Chromatography (HPLC) and Gas Chromatography (GC) instrumentation

Quality Systems

ECI Pharmaceuticals utilizes the Six Systems (Quality Systems) approach recommended by the FDA to develop and maintain our Quality Assurance program.
  • Quality System – Documentation change control; handling of complaints; investigations; training; final review and release of materials; products and documents; auditing; document maintenance, and regulatory compliance.
  • Materials System – Materials and components sourcing, qualification, testing, handling and storage
  • Facilities and Equipment System – Facilities and equipment design, procurement, installation, calibration, validation, maintenance and use
  • Production System – Process validation, manufacturing and scheduling
  • Packaging and Labeling System – Validation, label control/accountability and packaging
  • Laboratory Controls System – Test method validation/verification, in-process/finished product testing, stability testing, reserve samples collection/storage and test results documentation and retrieval
The Quality Control laboratory provides raw material and component release, as well as in-process and finished-product testing for our products. Core analytical testing is supported by High Pressure Liquid Chromatography (HPLC) and Gas Chromatography (GC) instrumentation linked to a lab data-management system. Several Type I and Type II dissolution units equipped with auto sampling systems are available.