The planning of facilities and equipment for the manufacture of pharmaceutical products in today's world presents a major challenge. A large number of requirements have to be met: not only the entire canon of engineering standards, but also the specific Good Manufacturing Practice (GMP) requirements. There are, however, important differences between standards and GMP requirements. Standards can normally be implemented without knowledge of the requirements for the final product. This does not apply to GMP requirements. GMP compliance cannot be achieved without knowledge of the product.
Schedule, budget and resource planning for the overall project are crucial for project management. The course of many projects shows that the time required for qualification and validation is consistently underestimated. As a result, deadlines are frequently not met and budgets exceeded. The cause is normally not to be found in the implementation of the qualification/validation itself, but in the incorrect weighting given to these tasks by project management, especially during the planning phase.
Projects become efficient when the first phase of qualification (DQ) is carried out in a detailed and conscientious manner with the required time and human resources made available. The first phase of a project decides whether the budget, schedule and quality of implementation targets will be met. The degree of effort required and the difficulties faced when correcting an error is directly related to when the error is discovered – it's like a shirt that has been incorrectly buttoned.
Compliance with the GMP requirements for a technical system is an important objective for an investment project in the pharmaceutical industry. Inadequate project management can put a company in a predicament when qualification has not been successfully completed and the technical system is subsequently not commissioned on schedule.
Good project management shortens project realisation times, lowers project costs and increases the quality of the investment. A consequent and appropriate type of qualification can help achieve these goals.
The make-up of the qualification team is also crucial to the success of the project. All relevant departments should be represented proportionately and effective communication between the departments must be ensured.
The declared objective is the joint development of optimum solutions. In practice, however, communication between representatives of the pharmaceutical and technical departments does not always run smoothly. The project manager is responsible for detecting these issues at an early stage and intervening to resolve them.
Along with organisational tasks, the planning of meetings is an important part of project management. Regular meetings that include all persons involved in the project should be scheduled that deal exclusively with aspects of qualification.
If work is outsourced to third parties, it is particularly important to define how knowledge is transferred from the contractor to the client and how this knowledge is to be preserved. Interfaces and ways of transferring information must be defined.
Continuous traceability must be ensured for projects. This requires a structured project documentation that covers the following areas within a project:
The project manager is responsible for properly documenting the project and ensuring traceability of the course of the project at a later stage. The QS system defines approval procedures for key GMP documents, e.g. QMP/VMP.
In order for project management to meet the requirements, qualification must be given adequate consideration in the project, and the project manager must monitor the status of qualification from project start to completion. Design qualification (DQ) is of major importance to facility planning.
The user requirement specification and the functional specification are important documents and are usually created at the start of a project. The user requirement specification includes the requirements of the future user of the facility and describes, in particular, the requirements to be met if the necessary product quality is to be achieved; GMP requirements are also included. The functional specification, on the other hand, is the supplier's response to the requirements outlined in the user requirement specification. The functional specification often comes in the form of a quotation. Then the requirements from the user requirement specification must be outlined and technical solutions for the implementation of these requirements determined. These two documents are reviewed during the design qualification.
The responsibilities for the project duration must be specified at an early stage. Figure 1 shows how tasks can be assigned for a facilities project.
|Qualified Person||Overall legal responsibility for implementation of the qualification/validation in accordance with the specifications||Approval of qualification documents|
|Legal responsibility for the accuracy of documents with regard to all pharmaceutical aspects||Approval and correction of qualification documents for Production|
|Head of Quality Control||Legal responsibility for the accuracy of documents with regard to all pharmaceutical aspects||Approval and correction of qualification documents for Quality Control|
|Quality Assurance||Formally correct handling of documents and projects||Release of qualification documents|
|Engineering||Correctness of content of documents with regard to all technical aspects||Approval and occasional creation of qualification documents|
|Supplier||Correctness of content of documents with regard to all technical aspects||Creation of qualification documents|
|Associated experts||Expertise in specific areas||Revision of qualification documents|
|One person must be nominated as team leader.|
Figure 1: Responsibilities in the project team
The text is an excerpt of the GMP MANUAL, Chapter 4.A Facility Planning.
Editor in Chief
Maas & Peither AG - GMP Publishing, Schopfheim, Germany