Efficient document routing and timely task completions are critical. Communication is the key to this process. A document tracking system (DTS) can significantly increase cross-functional communication and allow the documentation effort to proceed in an organized way.
This article provides guidelines, tools, and recommendations on managing GMP documentation requirements to support the startup of a biotech facility. The methodology is based on experience with biotech startups and includes extensive discussion of identification, prioritization, routing, and management of key documents such as validation protocols, standard operating procedures (SOPs), and batch records. We also discuss the importance of matching the documentation approval cycle to the actual start-up project plan and milestones, managing the workload of team personnel and implementing tools to effectively oversee the process and highlight potential conflicts.
START-UP PLANNING For any new biopharmaceutical facility, the documentation effort is closely tied to the overall planning effort. The goal of the start-up team is to match the construction, equipment move-in, and validation schedules with the support systems, documentation, hiring, and training timelines. Detailed planning of when to bring in critical managers and how to train new personnel is crucial. New personnel will execute the planned tasks and will be needed to write, review, and approve required documentation to support the startup. The project manager will overlay the different schedules and generate a consistent timeline to ensure that activities from construction through starting GMP production are coordinated. The documentation team will base its plan on the master plan. This is a golden opportunity to streamline overall documentation procedures to avoid transferring inefficiencies to the new facility.
The documentation team needs a set of goals and objectives. The start-up team leader, the documentation team leader, and other members of the start-up team share the task of establishing goals and objectives. Typical objectives include:
Establish Documentation Team A project manager with technical as well as documentation skills should lead the team. Make sure to acquire significant participation from the quality assurance (QA) documentation department and the start-up team. Pull permanent members from all departments that identify, develop, review, or approve documents. Other groups may need to participate in the process as needed.
There are several key attributes of a successful start-up documentation team: