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ISPE (International Society for Pharmaceutical Engineering)

ISPE (International Society for Pharmaceutical Engineering)

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GMP, manufacturing, quality and compliance for pharma/biotech.

2026 ISPE Europe Annual Conference: Erbe 4.i: Sustainable Benchmark - From Vision to GMP-Operation
Video•Mar 31, 2026

2026 ISPE Europe Annual Conference: Erbe 4.i: Sustainable Benchmark - From Vision to GMP-Operation

At the 2026 ISPE Europe Annual Conference, Erbe introduced its 4.i Sustainable Benchmark project, demonstrating how a GMP‑compliant clean‑room can be built within a timber‑frame structure. The presentation positioned timber as a viable alternative to traditional steel‑concrete plants for pharmaceutical and metac‑chemical production. The speakers highlighted timber’s lightweight nature, long‑span capability, local availability, low‑carbon footprint and recyclability. Coupled with a 5,500 m² photovoltaic canopy, the facility achieves some of the highest energy‑saving metrics recorded in Europe, targeting near‑zero operational emissions while maintaining strict quality standards. “You don’t normally associate a clean‑room environment with timber construction,” the presenter noted, underscoring the paradigm shift. The project’s service strategy integrates continuous monitoring, modular maintenance and renewable energy, illustrating a practical pathway from vision to GMP‑ready operation. If regulators and industry adopt this model, future pharma sites could lower capital and operating costs, meet tightening sustainability mandates, and enhance corporate ESG profiles, reshaping the economics of drug manufacturing.

By ISPE (International Society for Pharmaceutical Engineering)
2026 ISPE Europe Annual Conference Session: A CQV Early Engagement Checklist: BOD Thru DD
Video•Mar 30, 2026

2026 ISPE Europe Annual Conference Session: A CQV Early Engagement Checklist: BOD Thru DD

The video outlines an early‑engagement checklist for Commissioning, Qualification and Validation (CQV) that begins at the Basis of Design (BOD) and continues through due‑diligence activities. It explains why most issues surface during the CNQ phase—earlier decisions funnel problems downstream—and introduces a...

By ISPE (International Society for Pharmaceutical Engineering)
2026 ISPE Europe Annual Conference Session: Implementing Data Integrity: Real-World Lessons
Video•Mar 17, 2026

2026 ISPE Europe Annual Conference Session: Implementing Data Integrity: Real-World Lessons

The ISPE Europe 2026 conference session focused on practical strategies for implementing data‑integrity controls across pharmaceutical manufacturing and quality systems. Presenter emphasized closing the gap between rapid technology adoption and sustainable regulatory compliance. Attendees learned how to replace paper‑heavy audit reviews...

By ISPE (International Society for Pharmaceutical Engineering)