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Choosing your contractor is discussed in more detail elsewhere (3). The answers to these questions have significant bearing on the route adopted. Approach Once the choice of management for the project is made, a team must be assembled under a project manager, who Validation Master Plan Standard Operating Procedures Computer Qualification Identify Items to be Qualified Operation Qualification Cleaning Qualification Identify Systems & Subsystems Identify Systems to be Qualified FDA Life Cycle Approach Design Qualification Approved Design Documentation Specification Personnel •Training •Experience Includes Dust Control Installation Qualification List Items to be Qualified Calibration Process Qualification of Products & Processes Identify Items to be Calibrated SOPs Records Figure 4 Facility and equipment qualification plan.

Purpose of Design Development The main objectives of this design development phase are as follows: 1. To establish a basis for detailed design 2. To progress the design to establish the technical, capability, and safety aspects of the project 3. To provide the necessary design data to evaluate and, subsequently, comply with the regulatory, environmental, and planning requirements of a project with the relevant authorities 4. To provide an improved cost estimate and so enable sanction of the project.

Qualification Activities Qualification Cost At this stage, the qualification of the facility is in its earliest phase and the emphasis must be on the qualification of the design. This can be completed by reviews of the proposed design against defined user requirements Clearly if the conceptual phase is to provide a cost estimate for the project, then the qualification must be similarly estimated at this stage. Some form of qualification statement and policy is required to at least determine Figure 3 layout.