Background
A leading global animal health company acquired an API manufacturing facility in Ireland that had been in
a decommissioned state for two years. To bring the site back into operation, it was essential to design and implement a comprehensive Commissioning, Qualification & Validation (CQV) strategy aligned with international regulatory standards.

Challenge
The facility required a full restart program — from recommissioning utilities and equipment, to establishing
a compliant Quality Management System (QMS), to ensuring readiness for new product introductions.
The project needed to satisfy strict requirements under ICH Q7 guidelines, as well as the client’s own global quality framework, within tight regulatory and business timelines.

Approach

• Developed and delivered a site-wide restart strategy to ensure compliance and operational readiness.
• Implemented a full validation lifecycle for new process introductions using a risk-based approach.
• Led the migration of the legacy QMS to align with the acquiring company’s system, including the deployment of Veeva Vault for electronic document approval across CQV, engineering, and P&IDs.
• Oversaw validation planning and execution for the introduction of multiple new APIs.

Outcome

• Successful recommissioning and qualification of the site, enabling the introduction of five new APIs post-restart.
• Seamless transition to the new QMS, improving efficiency and compliance.
• Directly supported multiple successful regulatory inspections (HPRA and USFDA), ensuring the site’s operational and compliance readiness.

Key Takeaway
Strategic CQV leadership and a risk-based validation approach enabled the rapid and compliant restart of
a decommissioned facility, supporting the successful launch of new products and smooth regulatory approvals.