News | February 19, 2020

Almac Clinical Services' Just In Time Manufacturing Operations Pass EU Regulatory Inspection

Almac Clinical Services, a member of the global contract pharmaceutical development and manufacturing organisation, 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 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 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 organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Source: Almac Group