Assistance with Canadian Regulations

SR & ED Tax Credit Program

  • Analysis of SR&ED work and expense eligibility
  • Identification and development of eligible projects and processes
  • Consultation, analysis and assistance in the preparation and submission of all claims processing financial and technical documents
  • R&D Support and prototype development

Certification

  • Implementation and maintenance of:
    • HACCP program
    • HACCP plan update
    • FSSC 22000 ( ISO, 22000, PAS 220:2008)
    • IFSQN BRC Food Safety Management System
  • SQF codes 1000/2000
  • GAP analysis and Risk Assessment per PAS 96 ( 2010 edition)
  • Allergen Prevention Program & Assessment
  • Regulatory affairs (Canada)
  • Food labeling
  • Gap analysis and Risk Assessment for food safety and quality programs
  • Site preparation for Health Canada license for manufacturing, packaging and distribution of DIN/NHP products.

GMP Compliance

  • Facility
    • Upgrade and maintenance per GMP standards
    • Implement logical flow of process and people
    • Environmental monitoring (air flow, temperature and micro)
    • Warehouse temperature mapping
    • Distribution Center implementation
    • Commissioning of HVAC, Compressed air and Dust Collector systems
    • Air balancing
  • 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 Manufacturing/filling equipment for treated foods
    • Development of preventative maintenance plan (PMP) for all plant equipment
    • Development of preventative maintenance plan (PMP) for utilities(HAVC, Water System and Refrigeration)
    • Set up and commission QC labs (Micro, Analytical) equipment and provide calibration services
  • Customer Compliance, Recall and Returns Management
    • Work with clients to establish required services
  • Training
    • Monitor and enhance personnel behavior 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 systems
  • R&D and QA Services
    • Prepare prototypes at HACCP approved at Agriculture Canada approved facilities
    • Co-ordinate samples for sensory evaluation
    • Design stability testing protocol for product shelf life
    • Co-ordinate all analytical and micro testing
    • Prepare nutritional claims for the product labeling
    • Design primary and secondary components
    • Design and conduct the shipping test
    • Develop scale-up batches
    • Develop working procedures
  • Manufacturing and packaging
    • Develop and streamline processes to achieve maximum capacity utilization
    • Improve existing processes to gain efficiency and quality
    • Maintain compliance by enrolling quality systems in batch processing
    • Design and implement manufacturing controls
  • Outsourcing (Supply Chain Management)
    • Develop and execute full project management to outsource raw materials, finished products and services required for R&D, Product Development, Stability and DIN application.
    • Develop specifications and establish AQL for shipments
    • Coordinate all required testing for bulk releases
    • Review C of A and batch documents for all incoming shipments
  • Logistics Services
    • Develop and Implement MRP/WMS systems
  • Audit Services
    • Health Canada, GMP, FDA, ISO, HACCP and customer audits
    • Address corrective action
    • Develop action plans and timelines
    • Prepare and communicate progress reports
  • TQM (Total Quality Management)
    • Develop quality vision and values
    • Develop and maintain Quality Manual
    • Quality management from design to first production batch
      • Design Feasibility/Vendor qualification
      • Identify equipment, capacity and process capabilities
      • Primary and secondary component development
      • Critical process step definition
      • First production batch monitoring
  • Project Management
    • Cost/benefit studies
    • Development and implementation of Business continuity planning(BCP)
    • Equipment specifications
    • Budget Management
    • Invoice payments
    • New product qualifications
    • Equipment changeover reduction
    • Supervision of contractors and maintenance people
    • Use of AutoCAD to update and improve layouts
    • Productivity improvement projects
    • Safety and ergonomic improvements
    • Continuous process improvements
    • Supervision of installations and modifications
    • JIT Manufacturing
    • Continuous Project updates/progress
    • Quality improvement projects
    • Automatic data collection
    • Zero in-process inventories
    • Redesign of packaged product
    • Improve material flow process