quality plans consultancyIngelyt can coordinate and perform all necessary operations from the definition of user requirements to the qualification of all facilities and equipment, among other activities, including:

  • User requirements definition (URSs)
  • Checking regulatory requirements both internally and with national and international health authorities of facilities
  • Making risk map (MaPP)
  • Conducting risk analysis and mitigation
  • Master Plan Validation
  • Drafting and implementation protocols DQ, IQ, OQ and PQ of equipment and facilities
  • FAT and SAT performed by suppliers
  • Drafting the specification and the site master file
  • Making pharmaceutical plans (classification of areas, pressures, flows of materials and people, equipment implementation)
  • Support for pharmaceutical local authorities approval (AEMPS, EMA, ANVISA, FDA)