Almac Clinical Services’ Just in Time Manufacturing Operations Pass EU Regulatory Inspection
February 18, 2020
Craigavon, N.I., 18 February 2020 – Almac Clinical Services, a member of the global contract pharmaceutical development and manufacturing organization, the Almac Group, today announced 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.
Almac’s innovative JTM service, Almac Adapt™ was launched globally in June 2019 and enables full late stage customisation of clinical supplies by postponing packaging and labeling 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 the highly respected body subsequently updated Almac’s manufacturing authorisation (MA) to include secondary packaging capabilities.
Almac 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 (North Carolina) and Singapore to 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.”
About Almac Group
A unique culture delivering exceptional solutions
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.
Our innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization that has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.
We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.