Background Denmark is one of the European countries that requires the Good Manufacturing Practices (GMP) certification to hospital pharmacies for medication compounding and delivery. In 2012, the Region HovedstadensApotek, the largest hospital pharmacy in Denmark, decided to invest in IV robotics to guarantee EU-GMP and GAMP compliance through the highest standards of safety, quality and efficacy in the compounding process. The go-live of this technology was preceded by a tough qualification aimed at assessing that the new compounding process was GMP compliant. The GMP qualification consisted of several validation procedures in sequence: design qualification, factory acceptance test, operational qualification, installation qualification and performance qualification.
Purpose Case study on how the technology can help the hospital pharmacy to be GMP compliant.
Material and methods A dedicated multidisciplinary team thoroughly studied the reference documentation: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. The analysis led to the definition of 89 user requirements specification (URS) associated with GMP requirements, for a total of 143 URS addressed in the tender. The GMP requirements covered several aspects, such as environmental conditions, equipment design, product safety and efficacy, documentations, alarm alerts and messages, user accessibility, training and maintenance, and data storage and recording. During the tender, the competing systems were challenged on each URS to verify their compliance.
Results The system that scored best in the tender evaluation was APOTECAchemo. It fulfilled 74 of the 89 GMP requirements from the beginning, and the manufacturer developed and validated the additional 15 before the qualification process. In November 2013, the Danish Health and Medicines Authority certified that APOTECAchemo was totally compliant with the GMP regulations and authorised the go-live. Since September 2016, 4 additional inspections have been successfully passed, without any deviation. Moreover, they approved the use of this robotic system in a class C cleanroom, different from the manual compounding that now requires a class B cleanroom.
Conclusion Installation of an IV compounding robot in full compliance with GMP regulations ensures benefits in terms of the highest level of preparation quality, operator safety, continuous monitoring of environmental conditions and reduction in human interventions in controls and reports.
No conflict of interest
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