Qualification and validation of a plant expansion

As part of a plant expansion for the production of a new dosage form, our client required a qualification and validation expert to act as a validation manager for the duration of the project.

Genipro was mandated to develop the master validation plans, plan the necessary resources and budget, manage the project validation team and review and approve all qualification and validation protocols.

The main challenge of this project was to harmonize the new plant section’s validation strategies and criteria with the policies and practices in place, while ensuring to meet regulatory expectations for the new plant. In addition, as these were innovative processes with no precedent in the pharmaceutical industry, and the associated production equipment prototypes were developped as the plant was being built, we had to deal with significant uncertainty and constantly adjust strategies to meet budgets and deadlines. The key was to properly identify the Critical Product Quality (CQA) attributes and adopt a risk management approach that allowed us to focus our efforts on the most important elements to ensure product safety.