Validation

ABL Europe’s validation department manages policy for performing the following high-level activities, captured in respective validation protocols and reports, defined from the validation master plan;

  • Small scale process qualification and characterisation studies
  • GMP process performance qualification lots / validation batches
  • QC methods validation
  • Equipment and facility validation
  • Aseptic process validation

In collaboration with the client as part of a lifecycle approach to process validation, ABL will perform a GAP analysis and quality risk assessment, to identify and document the process inputs (material attributes, process parameters) that are able to influence the quality attributes and process parameters, implementing a process design and control strategy as part of a product lifecycle approach.

ABL Europe’s Strasbourg facility is actively preparing for to be ready for preapproval inspection in 2021. Phase 3 clinical supply is also being performed from ABL’s Lyon facility, with a similar GAP analysis and project road map to be defined to support preapproval inspection for commercial supply. At the current time, approved / licensed products are not yet manufactured by ABL.