The GMP compliance certification is a significant milestone for Almac Clinical Services and its Almac Adapt
Almac EU headquarteres at the Finnabair Business & Technology Park, Dundalk, Ireland
Almac Clinical Services has announced that its Just in Time Manufacturing (JTM) processes have received GMP compliance certification from Ireland’s Health Products Regulatory Authority (HPRA). This assessment occurred as part of a recent inspection at the Group’s European campus in Dundalk, Ireland.
“This successful inspection is another significant milestone for Almac Clinical Services and, in particular, Almac Adapt," commented Natalie Balanovsky, JIT Manufacturing Solutions Manager, Almac Clinical Services.
For Balanovsky, the approval positively reflects Almac's commitment to supporting clients with their global clinical supply operations. "Receiving the official HPRA certification is testament to the quality and skill of our employees who are a key part of our ongoing strategy to meet both ongoing market and patient needs," Balanovsky concluded.
Receiving the official HPRA certification is testament to the quality and skill of our employees who are a key part of our ongoing strategy to meet both ongoing market and patient needs
The HPRA inspected Almac’s JTM suites and associated processes at the facility, which are capable of servicing clinical trials of all temperature ranges, from ambient through to ultra-low. No deviations or concerns were noted and the highly respected body subsequently updated Almac’s manufacturing authorisation (MA) to include secondary packaging capabilities.
Almac’s JTM service, Almac Adapt, was launched globally in June 2019 and enables full late-stage customisation of clinical supplies by postponing packaging and labelling until the site or patient’s need arises.
The company, part of Almac Group, has invested more than £4.4m in the development of the JTM service Almac Adapt and facilities globally, including its sites in Craigavon (UK), Dundalk (Ireland), Souderton (Pennsylvania), Durham (US), and Singapore. The upgrade meets the needs of the changing clinical trial landscape and reducing timelines, wastage and mitigating product shortages associated with conducting clinical trials.