BSQR 2005

The Blood Safety and Quality Regulations 2005 (BSQR) transposed the EU Blood Directives into UK law and remain in force post-Brexit. They apply to blood establishments (collection, testing, processing, storage, distribution) and to hospital blood banks (storage, distribution, compatibility testing). Blood establishments must hold an MHRA authorisation; hospital blood banks must be registered and are inspected on a risk-based cycle. The MHRA enforces, inspects and can suspend an authorisation.

Three requirements drive most inspection findings. First, a documented quality system covering personnel, premises, equipment, documentation, collection/testing/processing, storage and distribution, contract management, nonconformance and self-inspection. Second, traceability: full donor-to-recipient and recipient-to-donor traceability retained for at least 30 years, with unique donation numbering. Third, haemovigilance: serious adverse events and reactions reported to the MHRA through SABRE (Serious Adverse Blood Reactions and Events), which runs alongside the professional SHOT scheme.

Computerised systems used in these processes must be validated, access-controlled and audit-trailed to MHRA GxP data-integrity expectations — the same bar as Annex 11. V5 Ultimate provides the validated execution and quality layer around a cleared blood-bank system: SOP enforcement, calibration and environmental-monitoring gating, deviation-to-CAPA workflow, 30-year genealogy retention and one-click traceback packs. The tissue-side counterpart is the HTA licence regime.