Content focuses on the role and elements of a quality management system, its impact on the overall risk management approach, and its implementation scientifically and pragmatically. Case studies could demonstrate risk management's purpose, elements, and implementation, a quality management system, and systems validation.
Guidance Documents
Artificial Intelligence (1)
+Biotechnology (1)
+Commissioning & Qualification (5)
+Compounding (1)
+Containment (1)
+Data Integrity (16)
+Drug Shortages (1)
+GAMP® (15)
+Good Manufacturing Practice (1)
+Knowledge Management (6)
+Lifecycle Management (3)
+Manufacturing Operations (2)
+Microbiological & Viral Contamination Control (3)
+Pharma 4.0™ (1)
+Process Analytical Technology (4)
+Project Management (1)
+Quality Assurance (9)
+Quality Control (1)
+Quality by Design (4)
+Regulatory (4)
+Sustainable Facilities, HVAC, & Controlled Environments (2)
+Validation (13)
+Community Discussions
Community Discussions
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Pharmaceutical Engineering Magazine Articles
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ISPE in the News
Latest
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Process Intensification, Continuous Manufacturing, and Sustainability
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ISPE Releases the ISPE Good Practice Guide: Digital Validation
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Minimal Helper Plasmids May Improve AAV Production
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Researchers Use Bioprinting to Create Pancreatic Tissue Model
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Merck to Acquire SpringWorks Therapeutics for $3.9B
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UPS to Acquire Canada-based Andlauer
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Experts Discuss Biopharma Facility Design Considerations
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Central N.C. College adds Biotech Curriculum
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Biopharma Engineers Need Hands-on AI, Automation Experience
- Experts: Prepare for US FDA Review Delays
White Papers
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
