Elaboration and implementation of necessary documentation of Quality Assurance System according to Good Distribution Practice.

Audit of technical documentation, elaboration and implementation of Validation Policy in particular:

  • Master Validation Plan,
  • Validation Schedule,
  • Qualification of warehouse storage area,
  • Qualification of cold rooms and cold storage areas,
  • Staff qualification,
  • Transport and subcontractor’s qualification
  • Mapping of cargo space in vehicle.
  • Mapping of warehouses, analysis of measurement points, identification of critical positions
  • Qualification of system for temperature and humidity monitoring,
  • Designing of warehouse topography, designing of goods flow,
  • Rooms inventory, preparation of warehouses scheme,
  • Emergency procedure preparation.

Transport cost analysis, profitability of transport routes.

Our in-house qualified and highly experienced expert could engage to ensure quality control of all essential documents and records generated by the investigator/institution before, during and after the trial

  • We go a step further to evaluate and recommend documents that are essential, but not listed in section 8 of ICH GCP E6 which includes:—
  • Any forms, checklists and reports etc. generated from following quality system procedures.
  • QP certification of the IMP.
  • Assay method validation report for analysis of IMP or metabolite(s) in clinical samples,
  • Clinical Trials Regulation (EU) No 536/2014 Article 57 5 Document on risk proportionate approach in clinical trials
  • ATIMP traceability records,  documentation to demonstrate validation of trial-specific builds of computer systems (e.g. e-CRF 199 and IRT).