International Society for Pharmaceutical Engineering Inc
Follow our new page: https://www.facebook.com/profile.php?id=61556557244952 PROFESSIONAL SOCIETY OF PHARMACEUTICAL ENGINEERS
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Homepage | ISPE | International Society for Pharmaceutical Engineering Main navigation Secondary Menu Occupational ISPE GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems Second Edition section 2. 1. 4 states Quality Risk Management QRM is a systematic process for the identification assessment control communication mitigation and review of risks. In the pharmaceutical industry ensuring the safety quality and efficacy of products is paramount.
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International Society for Pharmaceutical Engineering Inc
We are proud to celebrate Johnson & Johnson Innovative Medicine as the 2025 ISPE FOYA Category Winner for Operations – Project Execution for the expansion of their BioCork facility in Ringaskiddy, Cork, Ireland. This milestone project significantly increased biomanufacturing capacity to support the production of biologic medicines in immunology and oncology—while also generating 180 new jobs in the local community. Executed within a live manufacturing environment, the expansion achieved seamless integration without unplanned downtime, a feat made possible by precise coordination, robust risk management, and close collaboration with key partners.
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International Society for Pharmaceutical Engineering Inc
In this case study, discover how a collaboration transformed a 50-year-old warehouse into a GMP-like plasmid production facility. This was achieved by leveraging prefabricated cleanrooms. This innovative approach integrated all utility systems, allowed renovation and construction to happen in parallel, and drastically accelerated the project timeline.
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