Almac Pharma Services Renew HPRA GMP Certification  for European Facility

February 12, 2024

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has received renewal of The Health Products Regulatory Authority (HPRA) Certificate of GMP Compliance for the company’s European facility.

The achievement comes following an in-depth, on-site 5-day audit conducted by an HPRA inspector from 6th – 10th November.  The certification applies to all labelling, secondary packaging including specialist ultra-low temperature processing,  analytical and distribution activities performed at the company’s Dundalk, Ireland facility.

The audit was overseen by Andrew Spence, Almac Pharma Services’ Head of Quality Assurance, and Fiona McDonnell, Dundalk’s Quality Manager supported by multiple subject matter experts from across Almac Pharma Services’  production, warehouse, labs, QP, global QA and technical quality teams.

The multi-departmental collaboration exhibited throughout this regulatory inspection, and our ability to maintain our reputable high standard of on time, in full (OTIF) service levels throughout the week, is testament to the commitment and professionalism of the entire Almac Pharma Services’ team.

Ian Markwell, VP Quality Assurance, Almac Pharma Services, said: “As a trusted partner to hundreds of global pharmaceutical clients we are committed to delivering best-in-class, tailored and quality-led services.  The renewal of our HPRA certificate is a clear reflection of how our people, infrastructure, policies, systems and skills combine to achieve excellence for our customers. Thank you to everyone who contributed to the successful outcome of this inspection at our Dundalk facility, and I look forward to continued growth of this site in the coming years.”

Almac Pharma Services’ Dundalk facility is one of four operational sites and is a dedicated Centre of Excellence offering Just-in-Time labelling, packaging and serialisation of all pharmaceutical products including advanced therapeutical medicinal products which are often handled at ultra-low temperatures (-20°C to -80°C).


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