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Case

Facility Monitoring System

Hospital Pharmacy, Central Denmark Region

Challenge

  • Requirement specification and risk assessment of a facility monitoring system (FMS) at the new hospital pharmacy in Gødstrup.
  • FMS is monitoring GxP-critical parameters that may have impact on product quality in biosafety cabinets, isolators, clean rooms, production rooms etc.

  • Support in the process of purchasing and vendor management

  • Time schedules covering both Gødstrup and Skejby (from design qualification to operation in Gødstrup in March 2022, and Skejby in Q1 2024).

  • Authoring of documentation including change control, validation master plans, validation plans and protocols/report including deviations.

  • Validation activities covering installation and operation qualification.

Vores nye FMS er vigtigt for patienternes sikkerhed. Derfor var det vigtigt for os at få kompetent rådgivning og hand-on support, så vi fra begyndelsen fik lagt den rette valideringsstrategi og sikret, at FMS var klar til idriftsættelsen af apotekets lokaler i Gødstrup.

Genau & More har været det rigtige valg med et højt fagligt niveau og gode samarbejdsrelationer. Det betød, at vi på trods af corona-nedluk og geografiske afstande mellem Skejby, Gødstrup og hjemmearbejdspladser altid har kunnet været trygge ved kvaliteten af arbejdet fra Genau & More.

Charlotte Quist Bjørn
Quality Manager, Hospital Pharmacy Central Denmark Region

Solution - Proces

  • The primary form of work was remote as the hospital pharmacy was under construction.
  • Bi-weekly status meetings with the project group including update on actions, documents, challenges etc.

  • Close collaboration with users and the team in Gødstrup in order to secure the design qualification.

  • Onsite/hands-on according to the implementation, configuration and qualification of the FMS, where working in the clean room and walking on celling. 

  • Validation Master Plan describing the chosen Validation Strategy based on the Golden-Light Strategy, where one IT-system needs to be implemented on two different sites in two different timespans.

Results

  • Identified deviations during installation and operation qualification were approved and closed.
  • All relevant documentation shared with the facility monitoring system (FMS) in Skejby was updated following the implementation/qualification. This included the risk assessment, design qualification report, and requirement specifications.

  • FMS was put into operation in March 2022 at Regionshospitalet Gødstrup with a total of 6 particle counters and 74 sensors measuring temperature, pressure and humidity.

  • Following an inspection from the Danish Medicines Agency, where the FMS project was of core interest for the inspectors during the 3-days inspection (2 inspectors), the implementation and operation of FMS was approved.

#Pharmacy #Hospital #Validation

Please get in touch to hear how Genau & More can help you and your company

Jonas Dahl Pedersen

Consultant
IT & Automation / GAMP, Computer System Validation, GMP, Project coordination

Lise Skytte Brodersen

Consultant
Design Control , GMP, MDD/MDR, Project Coordination, Medical Device

Charlotte Brus Mortensen

Senior Consultant
Quality Assurance, Deviations/CAPA, Design Control, GMP, MDD/MDR

Michael Holt

Consultant
IT & Automation / GAMP, GMP, Facilities & Equipment Validation, Computer System Validation

Henrik Johanning

CEO & Senior Consultant
IT & Automation / GAMP, Project Management, Management Consulting, GMP, Regulatory Affairs, Training