Know-how

Compliance and validation

Our professionals have the expertise and knowledge to design projects that comply with applicable regulatory bodies:

Food & beverage processing:
Canadian Food Inspection Agency (CFIA – FSAS/HACCP), United States Department of Agriculture (USDA)

Biopharmaceutical:
Food and Drug Administration (United States), Agence Française de sécurité sanitaire des produits de santé - S.F.S.S.A.P.S (France), European Medicines Authority (EMA) and the Health Products and Food Branch (Canada).

They work in close consultation with the validation experts so that the design complies with good manufacturing practices (GMP). Our validation experts produce the documents that show that the processes and infrastructure meet the standards, are “fit for use” and will consistently meet quality requirements.

Our team has developed a “typical content” that, by experience, they know is required. We will use your existing standards and documents or provide a complete verification and validation package. :

  • Commissioning plan
  • Commissioning protocols (FAT, SAT)
  • Validation master plan (VMP)
  • Standard operating procedures (SOP)
  • Quality Manual
  • Risk assessments
  • Qualification protocol (IQ, OQ, PQ, PV)
  • Summary report and deviation report
  • Tender documents – Regulatory affairs