FivePharma worked with the QA Manager of an Animal Health company to establish a secondary packaging facility in Ireland, tailored for the veterinary sector.
The comprehensive service package included developing and implementing a validation strategy, conducting audits, and training in GMP and HPRA inspection management.
In 2020 we worked with the QA Manager at an Animal Health company looking to set up a secondary packaging facility in Ireland, serving the veterinary 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, helped run the required Validations and conducted audits of the primary medicines (manufactured in the Americas) and packaging materials.
In November 2021 the HPRA (the Irish Competent Authority or CA) conducted its approval inspection and concluded that it the facility was operating in compliance with EU GMP. They recommended issuing an MIA and approved both nominated QPs.
The project moved through the following phases with our assistance;
FivePharma will continue to support the Client with QP support until they recruit their own and will provide ongoing consulting and supplier inspections as needed.
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