Content highlights regulations and guidance issued by international regulatory bodies and coalitions. Case studies could demonstrate the application of regulations and industry-generated guidance for global harmonization of compliance and product registration. Topics could include regulations, standards, practices, and guidance related to drugs, the environment, health, and safety.
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Guidance Documents
Active Pharmaceutical Ingredients (2)
+Advanced Manufacturing (1)
+Advanced Therapy Medicinal Products (1)
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+Good Manufacturing Practice (1)
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+Community Discussions
Community Discussions
Jul 17, 2025
Manufacturing Operations
Oral Solid Dosage
Jul 08, 2025
Information Systems
Artificial Intelligence
Data Integrity
Jul 08, 2025
Pharma 4.0™
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
May 22, 2025
Pharmaceutical Engineering Magazine Articles
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ISPE in the News
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ISPE Webinar: Life Cycle Approach to Process Validation - Stage 3 Implementation
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ISPE Academy's GAMP® Essentials Certificate Program
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US FDA to Accept Nitrosamine Mitigation Progress Reports
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4 Models for Centralized Comparator Sourcing
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Data Integration Enhances Bioprocessing Digital Twins
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Thermo Fisher to Acquire Sanofi Site in N.J.
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Texas College Develops Training Program for Handling Space-Made Biopharmaceuticals
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New Ligands, Equipment Improve Biopharma Purification
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ISPE Releases GAMP® Guide on Artificial Intelligence
- Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 - Materials and Components
White Papers
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
September / October 2023
Regulatory Trends & Quality Initiatives - Shortages of essential medicines around the world have…
January / February 2022
Emerging Leaders has grown from an initiative for interactions among early-career professionals and…

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