Biotech startups do not always have adequate plans for GMP documentation. Key issues typically overlooked include resource
requirements, routing pathways, approval procedures, and how the documentation plan relates to the overall project plan. A
disorganized documentation project can lead to delays, wasted effort, and potential regulatory compliance problems. On the
other hand, a well-planned and structured documentation effort often indicates that overall project timelines will be met.
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.
A database approach to track documentation progress provides visibility for current and upcoming tasks and increases cross-functional
communication to enable workload management. This article includes ideas on how to generate a documentation project schedule,
how to effectively route documents and manage approval tasks, how to identify reviewers, when to schedule signing parties,
and how to deal with potential documentation problems such as multi-site documents, document numbering, and document referrals.
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:
- creating a forum to discuss and solve documentation issues
- tracking documentation progress
- assessing impact on departmental workload
- reporting on schedule-impacting documentation issues to the start-up team.
Organizing a documentation team can be broken down into five steps (Figure 1).
Figure 1. The Five Steps to Establishing a Documentation Team
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
There are several key attributes of a successful start-up documentation team:
- Team goals and objectives are discussed and approved with participation of all members.
- The critical role that documentation will play in meeting the overall startup schedule is emphasized.
- Management and the start-up team clearly agree to support the documentation team.
- Time requirements from team members are identified and published as early as possible. (Requirements are typically light early
in the process — for example, three to five hours per week for most members including meetings.)
- The roles and responsibilities of the various team members are well established and publicized.
- Team guidelines and operational mechanisms such as agenda setting, meeting logistics, attendance requirements, the decision-making
process, the reporting process, conflict management, and meeting minutes are formalized.