Orderly Documentation Management During Startup - The documentation effort must follow a strict structure in order to succeed. - BioPharm International


Orderly Documentation Management During Startup
The documentation effort must follow a strict structure in order to succeed.

BioPharm International

Eylem Ay
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.

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.

APPROACH 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.

Figure 1. The Five Steps to Establishing a Documentation Team
Organizing a documentation team can be broken down into five steps (Figure 1).

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:

  • 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.

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