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Good Manufacturing Practice and chemotherapy preparation: A case study on implementation of a robotic system in a Danish hospital pharmacy.
European Statement
Production and Compounding
Why was it done?
In 2017, the hospital pharmacy has started a project for automated chemotherapy preparation aimed at managing the increasing workload, while ensuring highest level of quality and healthcare workers safety. In Denmark, the authorities expect hospital pharmacy preparation to be GMP compliant. To achieve the best implementation of APOTECAchemo, go-live was preceded by thorough qualification process and followed by robot performance evaluation in a GMP-pharmacy.
What was done?
A robotic system for aseptic preparation of cytotoxic drugs was implemented in the pharmacy-based, Grade C cleanroom compliant with Good Manufacturing Practice (GMP). Specific work organisation allowed the integration of APOTECAchemo into the pharmacy workflow, thereby steadily improving the robot productivity.
How was it done?
A multidisciplinary team defined 228 User Requirements Specification (URS) addressed in the tender and associated to GMP regulations to assess that the technology complied with the intended purpose. APOTECAchemo passed through all qualification stages: design qualification (DQ), factory-acceptance testing (FAT), installation qualification (IQ), site-acceptance testing (SAT), operational qualification (OQ), performance qualification (PQ). The implementation of robot was evaluated in terms of doses prepared, active ingredients processed, and % of the total production compounded. Data were taken from the management software and examined from June 2019 to September 2020.
What has been achieved?
The qualification process was completed in 13 months (from April 2018 to May 2019). APOTECAchemo fulfilled the requirements set in accordance with GMP regulations and went live in May 2019. In the first 15 months of operation, 20,968 doses were prepared with the robot, of which 18,242 infusion bags (87%) and 2,726 elastomeric pumps (13%). The number of active ingredients processed were 21, of which five (5-fluorouracil, calciumfolinate, irinotecan, gemcitabine, carboplatin) covered 58% of the total production. Average production of the robot increased by 39%, from 963 doses/month in 2019 to 1,582 doses/month in 2020. The % of the total production operated by APOTECAchemo rose from 20.9% (2019) to 46.4% (2020).
What next?
APOTECAchemo robot was successfully implemented in a fully GMP-compliant hospital pharmacy, thereby enabling the automation of the preparation process and the reduction of the manual operations. Through the evaluation performed, the hospital pharmacy decided to install a second robotic system to further enhance the automated production.