FivePharma assisted a multinational medical devices company in establishing a secondary packaging facility in Ireland to serve the human medicines sector.
Simultaneously, the client also requested our assistance in setting up wholesale distribution authorisation (WDA) facilities in the United Kingdom and the Netherlands.
In 2018 we worked with the QA Manager at a Multinational Medical Devices company looking to set up a secondary packaging facility in Ireland serving the human medicines sector.
FivePharma nominated 2 QPs on the MIA and trained the client personnel on GMP and HPRA Inspection management. The FivePharma team developed a Validation strategy and helped supervise the required Validations.
In June 2020 the HPRA (the Irish Competent Authority or CA) conducted its approval inspection and concluded that the facility was operating in compliance with EU GMP. They recommended issuing an MIA and approved both nominated QPs.
In parallel with the MIA process the Client also asked us to help with the establishment of a WDA in the UK and Holland. FivePharma provided 1 contract RP for each WDA and helped to localise the Irish procedures to suit the two WDAs. The two WDAs were granted by the end of December 2020.
FivePharma will continue to support the client with QP support and will provide ongoing consulting.
Fivepharma provided excellent support through the project phases from consulting, training and contract QPs and RPs. FivePharma also provided validation and CA Inspection support.
If your question can be answered in a 15 minute call then it’s free.