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 (5)
+Project Management (1)
+Quality Assurance (9)
+Quality Control (1)
+Quality by Design (5)
+Regulatory (4)
+Sustainable Facilities, HVAC, & Controlled Environments (2)
+Validation (14)
+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
Webinars
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ISPE in the News
Latest
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Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 - Materials and Components
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Sustainability Meets Strategy: Shape the Future of Pharma™ at the 2025 ISPE Annual Meeting & Expo
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Sun Pharma Plant in India Fails FDA Inspection
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Ultragenyx Gets CR Letter Over Manufacturing
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Heat Poses Risks to Pharmaceutical Supply Chain
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Renata Bangladesh Facility Receives EU GMP Certification
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Novo Nordisk Invests $112M in China Expansion
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Hikma Gets $250M From IFC to Expand MENA Access
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Amphastar to Expand Manufacturing in California
- FDA Backlog Brings Concerns for Canadian Drug Oversight
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…
