02.18.20
Almac Clinical Services 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.
Almac’s JTM service, Almac Adapt™ was launched globally in June 2019 and enables full late stage customization of clinical supplies by postponing packaging and labelling until the site or patient’s need arises.
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 HPRA subsequently updated Almac’s manufacturing authorization (MA) to include secondary packaging capabilities.
Almac has invested more than £4.4 million in the development of the JTM service Almac Adapt and facilities globally including its sites in Craigavon (UK), Dundalk (Ireland), Souderton (Pennsylvania), Durham (North Carolina) and Singapore to help meet the needs of the changing clinical trial landscape and reducing timelines, wastage and mitigating product shortages associated with conducting clinical trials.
Natalie Balanovsky, JIT, Manufacturing Solutions Manager, Almac Clinical Services commented: “This successful inspection is another significant milestone for Almac Clinical Services and, in particular, Almac Adapt™. It positively reflects our commitment to supporting our 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.”
Almac’s JTM service, Almac Adapt™ was launched globally in June 2019 and enables full late stage customization of clinical supplies by postponing packaging and labelling until the site or patient’s need arises.
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 HPRA subsequently updated Almac’s manufacturing authorization (MA) to include secondary packaging capabilities.
Almac has invested more than £4.4 million in the development of the JTM service Almac Adapt and facilities globally including its sites in Craigavon (UK), Dundalk (Ireland), Souderton (Pennsylvania), Durham (North Carolina) and Singapore to help meet the needs of the changing clinical trial landscape and reducing timelines, wastage and mitigating product shortages associated with conducting clinical trials.
Natalie Balanovsky, JIT, Manufacturing Solutions Manager, Almac Clinical Services commented: “This successful inspection is another significant milestone for Almac Clinical Services and, in particular, Almac Adapt™. It positively reflects our commitment to supporting our 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.”
