Implementing New Systems

A manufacturing site within a large global pharma organisation required a QP with experience in the manufacture of Investigational Medicinal Products (IMP) to be named on their MIA(IMP) license. The Qualified Person named on the license had left the organisation leaving a critical gap for the certification of batches for ongoing clinical projects.

The company chose to engage JWQC to provide an interim Qualified Person, experienced in the release of materials to clinical trial, rather than utilise commercial QPs from the wider organisation who did not have the relevant IMP experience. In addition, the company had identified an internal candidate for QP training who needed support and mentoring during this time.

JWQC was able to use its experience to help the client identify significant gaps in its non-IMP focused system.

During the course of the contract JWQC provided and supported:

• Batch certification of ongoing clinical trials.

• Upgrade of the existing systems to comply with the expectations and requirements for IMP manufacture

• Implementation of systems to support streamlined project management of IMPs.

• Re-design of the Product Specification File to facilitate an efficient QP certification process

• Training on IMP systems to a range of staff within the company

• Mentoring and coaching for the trainee QP

By working flexibly with the organisation over a period of two years JWQC provided a tailored consultancy service, working with a frequency to suit their circumstances. The contract was completed once the systems were implemented and the trainee QP had successfully achieved QP status.