Qualification & Validation

In every production and laboratory environment, the need for a tailored risk-based qualification and validation approach in line with the intended use is always near.

At pi Life Sciences, we bring do-ers and experts around your table to support the custom-made qualification and validation cycle in line with regulatory requirements, industry standards and future-proof methodologies. Our vast expertise in qualification ranges from (aseptic) formulation, filling, and packaging equipment to different types of laboratory instruments.

Next to process validation we provide support with cleaning, sterilisation, and decontamination validation activities.

Our expertise in qualification and validation entails the following: 

  • Validation strategy, planning and management
  • Risk and impact assessments
  • Verification of purchasing and operations activities
  • Pharmaceutical development (ICH Q7 / Q8) and qualification of process performance
  • Process, cleaning, decontamination validation
  • Specification and validation of process automation and monitoring
  • Validation of controlled temperature units in a production and laboratory environment with our proper logging system
  • Validation of aseptic processing and sterilisation processes
  • Validation of solid and oral dosing processes
  • Compliance with computer systems, electronic records, and signatures
  • Analytical/microbiological method validation (ICH Q2)
  • Qualification of laboratory equipment and software validation (GAMP 5, USP 1058)
  • Excel-spreadsheet-validation (GAMP 5)
  • Management of integration of GMP requirements in construction and procurement projects
  • Quality system management for projects and contractors
  • Design and management of specialised systems such as HVAC, cleanrooms; incl. critical processes and utilities and GMP-influenced computer systems
  • Decontamination, cleaning, and sterilisation systems
  • Assessment of Electronic Records Electronic Signatures (ERES) of Production and Laboratory Systems