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).