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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 ma
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