Compliance Services

  • GMP Compliance
    Maintenance and enhancement of GMP compliance regarding:
  • Facility
    • Upgrade and maintenance per GMP standards
    • Implement logical flow of process and people
    • Environmental monitoring (air flow, temperature and micro)
    • Qualification of distribution centers
    • Commissioning of HVAC, water systems, compressed air and dust collector systems
    • Air balancing
    • Warehouse temperature mapping
  • Equipment
    • Development and execution of validation protocols (IQ, OQ, PQ)
    • Calibration of equipment, quality monitoring device (GC, HPLC, UV, pH meter) and lab instruments
    • Confirm and execute 5 log reduction of microbial load for heat exchangers and thermal treatment systems
    • Design, install and commissioning of, manufacturing, filling and packaging equipment
    • Development of preventative maintenance plan (PMP) for all plant equipment & utilities (HVAC, Water System and Refrigeration)
    • Set up and commissioning of QC labs (Micro, Analytical) equipment and provide calibration services
  • Process
    • Develop & execute procedures for operational activities
    • Establish resource requirements to fulfill daily output
    • Optimize crew requirements & machine time utilization around a work center
    • Customer compliance, recall and returns management
  • Training
    • Monitor and enhance personnel behaviour in a GMP compliance facility
    • Develop and update all training documents
    • Develop site training program and establish timelines
    • Develop and conduct training programs for processing and on line QC inspectors
    • Intermediate (job specific, SOP-based)
    • Advanced (quality assurance key elements)
  • Documentation  
    • Update documentation and SOP’s as per GMP and current regulations
    • Maintain, document and change control system