Cleaning validation of a multi-product production line

At one of our clients an FDA readiness project was initiated to bridge the gaps to FDA compliance. Our senior consultants Paul Tiemeijer and Michelle Langeslag improved the cleaning validation strategy.

The scope of the project was cleaning validation of a multi-product production line. The product portfolio consisted of about 20 different injectables, all legacy products. Therefore a pragmatic approach was chosen, especially regarding the calculation of the acceptance criteria.

Paul Tiemeijer, our senior cleaning validation specialist, performed a gap assessment on the company’s cleaning (validation) procedures. Improvement was required in several areas, a.o. Design & Strategy, C&Q, Validation and Operations. Before starting validation activities open items from earlier phases in the life cycle were addressed. New worst-case products were defined, acceptance criteria were calculated and the validation and verification of analytical test methods were addressed. With the cleaning validation policy updated and procedures in place, performing the cleaning validation activities seemed straightforward. However, several challenges arose as the project progressed.

Michelle Langeslag accepted the role of hands-on project manager. She engaged the project team, communicated with management and maintained an effective project management plan. The team members had to perform a continuous balancing act between executing daily production activities and supporting the cleaning validation project.

Every manufacturing site, product, piece of equipment and process is unique. Multiple guidelines are available, which should be interpreted to apply to a specific situation. This requires experience with setting up a cleaning process, implementing a cleaning validation program and calculating acceptance criteria. Moreover, defending the cleaning validation program to authorities is crucial.

The project resulted in a robust cleaning life cycle, minimizing risk for the patient. Thanks to consultations with Paul Tiemeijer and the product and process experts on site remarkable progress was made. A significant advantage to working with Progress-PME is internal knowledge sharing: if you hire one consultant you get the support and expertise of fifty.

Michelle Langeslag

Senior Consultant
m.langeslag@progress-pme.nl
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