Client: Gødstrup Hospital Pharmacy, Central Denmark Region
About Gødstrup Hospital Pharmacy
The Hospital Pharmacy at Regionshospitalet Gødstrup plays a crucial role in ensuring the safe and effective use of medications for patients. It provides a wide range of pharmaceutical services, including the preparation and dispensing of medications, clinical pharmacy services, and medication counseling. The pharmacy works closely with healthcare professionals to optimize patient care and improve therapeutic outcomes. Located within the hospital, it is easily accessible to both inpatients and outpatients, ensuring that all patients receive the necessary medications promptly and accurately.
Challenges
- 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.
Outcome
- 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.
Solution - Proces
During the construction of the hospital pharmacy, our team primarily worked remotely to ensure continuous progress. We held bi-weekly status meetings with the project group to provide updates on actions, documents, and challenges. Close collaboration with our client and the team in Gødstrup was essential to secure the design qualification.
Our work also involved onsite, hands-on activities for the implementation, configuration, and qualification of the Facility Management System (FMS). This included working in the clean room and walking on the ceiling. Additionally, we developed a Validation Master Plan that outlined our chosen Validation Strategy based on the Golden-Light Strategy. This strategy required the implementation of one IT system at two different sites within two different timespans.
Quote: "Our new FMS is important for patient safety. Therefore, it was important for us to get competent advice and hands-on support, so that we could set the right validation strategy from the beginning and ensure that the FMS was ready for the commissioning of the pharmacy premises in Gødstrup. They have been the right choice with a high professional level and good working relationships. This meant that despite the corona lockdown and geographical distances between Skejby, Gødstrup and home workplaces, we have always been able to be confident in the quality of work from them.
Charlotte Quist Bjørn, Quality Manager, Hospital Pharmacy Central Denmark Region
Challenge
Our client need support with executing a requirement specification and risk assessment for a new facility monitoring system (FMS) at the new hospital pharmacy in Gødstrup(DK), supported purchasing and vendor management, managed time schedules for Gødstrup and Skejby (DK), authored documentation, and performed validation activities.
Outcome
Deviations during installation and operation qualification were approved and closed. Documentation for the facility monitoring system (FMS) in Skejby was updated. The FMS, with 6 particle counters and 74 sensors, became operational at Regionshospitalet Gødstrup in March 2022. The Danish Medicines Agency approved its implementation and operation after a 3-day inspection.
