All pharmaceutical validation projects are labor and capital intensive, and each must be planned and managed carefully. Numerous tasks and activities must be identified early and then scheduled to support the project completion date. Stakeholders such as the Quality Assurance (QA) and Calibration–Metrology departments must be alerted to impending increased workloads under compressed time frames. Standard operating procedures (SOPs) and protocol formats must be developed, test equipment must be purchased or rented, and contractors must be evaluated and hired. Managers must decide whether the US Food and Drug Administration will participate in the design review process, and if so, what will be the agency's exact involvement and participation. Considering the set of activities and programs that require timely completion, pharmaceutical validation projects must be carefully organized, managed, and monitored.
Part I of this article covered the following four critical components common to all successful validation projects: design review to ensure GMP compliance, project scope definition, project labor and cost estimating, and validation master plan development (1). Part II of this article introduces three additional programs, thereby providing validation project managers and participants the knowledge to plan and execute a project properly, no matter how difficult or complex. This final article also examines activities that are initiated well after project inception and often continue to project completion and operations:
protocol and SOP development, scheduling, and implementation;
turnover package preparation;
deviation and discrepancy management.
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