COMPLIANCE & VALIDATION 

PHA.SE. supports its Clients on Compliance and Validation services related to either new systems, equipments and facilities and to existing systems (legacy systems). In particular PHA.SE. develops and manages the following activities:

  • Compliance & Validation Status Audit
  • Validation Master Plan
  • Cleaning Validation
  • GMP & Compliance Assessment
  • Risk Analisys
  • GMP review
  • Media Fill & Process Validation
  • Computer System Validation
  • Process Utilities Validation (PW, WFI & CS)
  • Design Qualification (DQ) & cGMP Review
  • IQ/OQ/PQ Protocols and reports for equipments, plants, manufacturing and packaging lines
  • QA documentation and procedures compiling
  • SOPs issue and execution (where needed)
  • Validation Periodic Review
  • Deviation management