Engineering + Validation

Ensuring Seamless Fill Line Installation for OSD Excellence

Pharmalliance Consulting Ltd partnered with a leading oral solid dose (OSD) manufacturer to oversee the successful installation and qualification of a new filling line at a Contract Manufacturing Organization (CMO) site.

With regulatory compliance and operational integrity at stake, Pharmalliance’s role as Subject Matter Experts (SMEs) and client representatives was pivotal in ensuring validation compliance.

Our scope included:

Engineering Design Oversight: Review and approval of vendor documentation to ensure cGMP compliance and operational efficiency.
Validation Documentation Support: Generation, review, and approval of critical validation documents to establish a robust compliance framework for the new filling line.
On-Site Oversight: Provision of on-site SME support during the installation and qualification phases to ensure adherence to validation protocols and regulatory requirements.
Collaborative Execution: Encouraging teamwork and knowledge sharing, fostering a unified commitment to project goals across all stakeholders.

Non-compliance risks such as operational delays and regulatory setbacks demanded expert intervention.

Pharmalliance ensured that the project met stringent validation standards, aligning with regulatory expectations while enabling the timely installation and qualification of the filling line.

Transform your complex installation projects into compliance successes.