Global audit program for leading CDMO

Background

The client has expertise across the drug development lifecycle and offers services including drug discovery, clinical trial supply, commercial-scale manufacturing, and specialised diagnostics. They operate in sectors such as clinical trials, pharmaceutical manufacturing, and biomarker discovery, and their primary business objectives are to accelerate drug development timelines, optimise clinical supply chains, and deliver high-quality, compliant solutions that enable their clients to bring innovative therapies to market effectively.

Challenge

This CDMO was facing challenges due to a combination of resource limitations, limited specialised expertise, and a surge in unplanned work. The rapid increase in client demand and project complexity outpaced internal capacity, leading to resource bottlenecks across some audit schedules over a two-year period. This strained existing teams and impacted timelines and productivity. The company needed a scalable solution to overcome these barriers while remaining flexible enough to support immediate needs and up-skill internal staff.

Solution

To fully support the CDMO, the first step was to understand the project’s resource requirements and any specific client requests. The audit program consisted of over 20 audits across multiple countries, including Italy, Ireland, Spain, the United Kingdom, the United States, France, India, and Greece. The program covered Contract Testing Laboratories, Excipient Manufacturing, Packaging, and Warehouse and Distribution networks. A project team was formed to support the program, including a Project Manager, a Lead Auditor, and specialist subject matter experts where required. Dates were confirmed with each vendor, and agendas were issued three to four weeks prior to on-site audits. Internal stakeholders and staff were also required to attend several audits, providing exposure and training for less experienced auditors. Each audit was conducted, written up, reviewed, and approved, and RRxCo continues to support the client’s ongoing audit schedule.

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