Lifecycle Management Case Study

The Brief:

Lafferty were engaged by one of our clients to provide project management and drug product (fill finish) SME level experience to a critical project within a commercial fill finish facility. The project entails the significant upgrading Of fill line, isolator, and capping equipment. The facility is critical to the supply chain for key growth products; therefore, the planning and risk management Of the project work is Of utmost importance to the business.

The Approach:

Lafferty were engaged to lead the client project engineering team in the design and deployment of this project to ensure risk to ongoing commercial operations is minimised.
Lafferty engaged key internal stakeholders in quality, sterility assurance, operations, CQV, and regulatory affairs to obtain buy-in to the scope, schedule and identify all risks. We identified design scope and produced bid documents for the client to engage engineering design firms where necessary.

■ Lafferty facilitated the initial scoping of the various upgrades required across the fill line, isolator, capper, and scope associated with a conversion of a Grade B room to Grade C. We also identified all client user requirements and documented the same for review and approval by all client internal stakeholders.
■ Lafferty developed a high-level project schedule for communication to key stakeholders and senior management. We facilitated multiple interactive planning sessions to fully develop the project schedule and its impact on product availability.
■ We identified key business risks, established a project risk register and assigned mitigation responsibility as appropriate.
■ We provided technical SME input to design reviews Of vendor technical submittals associated with the process equipment upgrades.
■ Lafferty inputted into the shutdown planning of each of the interventions required to implement the upgrades, including planning of installation and CQV activity associated with the upgrades.

Drug Product

Lifecycle Management Case Study

The Outcome:

The following outcomes were realised for the client:
■ Detailed identification of the user requirements converted into project scope for each of the upgrades.
■ SME level input to the technical reviews required on the project.
■ Detailed project schedule and robust planning of the shutdown, CQV, media fill, and regulatory strategy for return to commercial production and realisation of the project benefits.
■ Implementation of a risk management plan including mit- igation for key risks and a defined escalation process with project governance.
■ Improved internal coordination and stakeholder