Maximize efficiency and effectiveness in your validation projects by utilizing multi-disciplinary teams. The term “Validation,” as used in this white paper, will be taken to mean either or both activities of Qualifying systems and facilities as fit-for-purpose (IQ/OQ/PQ) and the Process Validation of manufacturing processes and procedures (PQ or PV).
Lean project management strategies incorporate subject matter experts (SMEs) in cross-functional teams. For example, commissioning equipment with computerized functions needs to be validated by the computer systems validation SME and the commissioning and qualification validation SME. This white paper discusses some considerations for using a multi-disciplinary team approach to sitewide or corporate Validation project planning, oversight, execution, and approval.
Table of Contents
Overview of Multi-Disciplinary Validation Teams
Establishing Validation Teams
Complexity and Scope
Criticality and Risk
Availability of Required Personnel
Organizational Experience Level
Time and Project Length
The establishment and management of multi-disciplinary validation teams are crucial to managing changes in the modern Pharmaceutical and Biopharmaceutical industries. These teams are typically responsible for the review, planning, and approval of changes (additions of or modifications) to equipment, facilities, systems, and processes with the potential to impact product quality. Project Management can significantly impact project quality, cost, and time through the decisions and mechanisms they choose to implement. Third-party resources and service firms can help with current developments in industry practices and standards and have the potential to more than pay for themselves in terms of money and time saved.
PSC Biotech® Project Management
PSC Biotech® project management experts have a strong track record of delivering projects and offering the best solutions for all kinds of projects in the life science industry. We follow current Good Practice regulations, the Project Management Institute’s Best Practices, and ISPE’s Good Practice Guides. Our Project Life Cycle services include project initiation, planning, execution, monitoring and controlling, and closure. Throughout the Life Cycle of a project, our primary focus is on delivering our project, on time, on budget, and to specifications.
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PSC Biotech provided exceptional professionalism in project planning and time management, qualification document designing, and the executive power of completing qualification tests and solving qualification deviations.
PSC Biotech® delivered a detailed service quotation including personnel, transportation, and accommodation to our client, a global biopharmaceuticals development and manufacturing company located in Taiwan.
PSC consultants performed qualification protocol and summary generation, and qualification execution.
PSC Biotech provided CQV and Metrology services for this project. Client required rapid use of refrigerated storage trailers to handle warehouse overload. Each trailer required sensor calibration, engineering study for temperature profile, installation qualification, and operational qualification with temperature mapping. PSC consultants performed the calibration, ran engineering studies, wrote and executed qualification protocols, resolved deviations, and closed out reports.
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PSC Biotech Services provide fast, budget-friendly, high-level expertise.
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