EPQMS PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM

Description

NHS Wales Shared Services Partnership Pharmacy Technical Services provide a wide range of activities essential to patient care, including the manufacture and aseptic preparation of medicines. These services operate within a highly regulated framework overseen by the Medicines and Healthcare products Regulatory Agency (MHRA) and must comply with Good Manufacturing Practice (GMP) standards and Data Integrity requirements. A robust and compliant Pharmaceutical Quality System (PQS) is therefore fundamental to ensuring safe, effective, compliant, and uninterrupted patient supply.Recent regulatory updates (EU GMP Chapter 4, Annex 1) place greater emphasis on the strength of PQS in supporting quality assurance, validation, and data management. Traditional manual or paper-based processes are no longer sufficient to meet MHRA expectations. To address this, an Electronic PQS (ePQS), Bizzmine, has been procured in line with a comprehensive set of Functional Specification Requirements. This system provides a resilient, regulatory-compliant solution tailored for the TrAMs hubs, including the new Radiopharmacy aseptic unit at IP5.Retention of the current ePQS software platform is essential to maintain regulatory compliance. Any change of system would necessitate a full redesign and revalidation in line with MHRA Good Manufacturing Practice and Annexes 1 and 11 of the EU GMP Guide, including comprehensive qualification and revalidation of all functions and processes. Given the complexity of these requirements, the design and validation of the current Pharmaceutical Quality System has already taken over two years; repeating this process would introduce significant compliance risks and cause substantial delays to the Radiopharmacy build.The existing system has been configured and is undergoing validation to fully meet Annex 1 and Annex 11 requirements, including electronic records management, audit trails, and data integrity safeguards. Continuing with this platform avoids duplication of effort, ensures uninterrupted compliance, and mitigates the risk of regulatory findings that could compromise unit approval.Procurement of an alternative ePQS software solution is not feasible given the regulatory framework and extensive revalidation requirements. The incumbent supplier is the sole provider capable of delivering the licences and support needed to maintain the current ePQS in an operational and compliant state. In light of this NHS Wales Shared Services Partnership are looking to undertake a direct award with the incumbent suppliers via a Direct Award under Schedule 5 paragraph 7 of the Procurement Act 2023 ‘The public contract concerns the supply of goods, services or works by the existing supplier which are intended as an extension to, or partial replacement of, existing goods, services or works in circumstances where—(a)a change in supplier would result in the contracting authority receiving goods, services or works that are different from, or incompatible with, the existing goods, services or works, and(b)the difference or incompatibility would result in disproportionate technical difficulties in operation or maintenance’.