Getting the Product to Market Faster while Still Meeting FDA Regulations
The Batch Records is a critical part of any drug production process because it documents exactly what happened on a particular run of that drug category. The pharmaceutical company I worked with had batch records of over 400 pages. The process was complex, had multiple inspections, rework, and duplication of effort. Often delays in the Batch Record prevented the product from going to market. Yet the Batch Record had to meet FDA regulations! Management wanted it fixed so the company could meet expanding demand.
Ideas, Involvement, and Implementation
We had two objectives:
- Streamline the Batch Records process
- Develop the skills and capability of company manufacturing employees
We selected a cross functional working team, human resource manager, management leaders, and identified executive sponsors. The sponsors set ambitious business goals, we built a project plan and timeline, the HR manager provided team skills, we established a war room, and the team got started. They operated as a self-directed work team. In just 6 weeks they reinvented the Batch Records process, and engaged manufacturing and design employees to support the implementation.
We created a new generic batch records form which linked to more specific procedures. The regulatory consulting team who reviewed the solution said they had never seen such a creative solution. Batch record entries went form 1021 to 749, a decrease of 26%. Productivity on the floor in the documentation area increased by over 50%. The working cross functional team showed they could really do the work. The Senior VP said of the team, “They hit a home run!”