Remediation

Pharmalliance Consulting Ltd partnered with a leading pharmaceutical manufacturer in Ireland to remediate critical compliance and operational challenges in their oral solid dose (OSD) facility.

With regulatory risks looming, the project aimed to enhance efficiency across packaging operations, warehousing, labeling, material control, and QA processes while aligning operations with cGMP standards.

Our expert team executed a detailed oversight program, including:

• Operations: Streamlining packaging setup, cleaning, and changeover processes to reduce downtime and boost throughput.

• Warehousing: Enhancing material handling efficiency, improving inventory tracking, and ensuring labeling accuracy to protect product integrity.

• Quality Assurance: Overhauling QA investigations, CAPAs, and batch release processes, leading to reduced compliance risks and faster investigation resolutions.

• Engineering: Optimizing fill line reliability through enhanced calibration and maintenance programs, backed by rigorous training and KPIs.

The risks of non-compliance were significant: potential regulatory citations, operational inefficiencies, and market interruptions. 

Pharmalliance’s intervention mitigated these risks and positioned the client for sustained operational success and audit readiness​.

Are compliance challenges jeopardizing your operations? 

Reach out to us to secure your compliance and operational excellence.