Large-Scale Change for Drug Manufacturer

QSN assisted a drug manufacturing company with the successfull completion of a large-scale change initiative which significantly increased their production volumes to support the launch of several new parenteral products.

Company Profile

• Established in the late 30’s.
• Leading research-based pharmaceutical company in Europe.
• Therapeutic areas include: Immunology, oncology, neuroscience, cardiovascular and metabolic diseases, and infectious diseases and vaccines.
• State-of-the-art packaging and filling operations, compliant with current GMP’s (FDA 21 CFR Parts 210/211), but there were still some legacy manufacturing lines being used for production.

Business situation

The drug manufacturer wanted to increase production volumes to support the launch of several new parenteral products. They also saw an opportunity for increasing efficiency so that they could supply product through new major distribution channels.

Technical situation

The drug manufacturer had the internal expertise for changing over the legacy manufacturing lines and creating defined cells for high speed production. Their goal was to replace two legacy lines and design and build 3 complete top-loading packaging lines for secondary packaging. They did not have the additional bandwidth, however, for the management of the change control process, coordination with the equipment manufacturer, or the management of the project activities.

Solution

QSN was commissioned to facilitate and coordinate all project activities related to the build of the manufacturing lines. QSN developed a 6-month project schedule with the cooperation of the European operation, corporate domestic function, and the quality organization. Weekly meetings were arranged with a large cross-functional team, with QSN responsible for facilitating the meetings, updating project schedules, mitigating project risks, and managing team communications. QSN was also responsible for tracking communications with the equipment manufacturer to ensure smooth installation and set-up of the equipment. QSN worked with the quality department to initiate the change controls required to ensure that the changes would be introduced in a controlled and coordinated manner, required by their quality management system, for compliance.

Benefits

QSN was instrumental in leading the efforts responsible for the successful factory acceptance tests and process validations required to prove out the repeatability and reproducibility of the manufacturing lines. The lines were up and running ahead of schedule in preparation for the product rollout through expanded distribution channels. The change control was closed out upon completion of all testing. The client was left with a roadmap for changing out the remaining 2 legacy lines.