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)
+Biotechnology (3)
+Critical Utilities (5)
+Drug Shortages (2)
+Good Manufacturing Practice (1)
+Investigational Products (3)
+Knowledge Management (2)
+Lifecycle Management (2)
+Manufacturing Operations (3)
+Microbiological & Viral Contamination Control (6)
+Packaging (1)
+Quality Assurance (2)
+Quality Control (1)
+Regulatory (5)
+Sterile Products (1)
+Supply Chain Management (2)
+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
A New Regulatory Approach to Drive Sustainable Medicines
To enable changes across the pharmaceutical industry, sustainability should be included alongside…
ISPE Briefs: New Guide Helps Maintain and Establish PPPQMS
ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality…
2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More
The 2022 ISPE Aseptic Conference Regulatory Panel session on 15 March was as always one of the…
Regulatory Landscape for Raw Materials: CMC Considerations
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients…
Streamlining Postapproval Submissions Using ICH Q12 & SCDM
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but…
Evolving China’s Regulatory System in Alignment with ICH
With the Chinese government initiating drug regulatory reform in 2015 and China joining the…
New EU AI Regulation and GAMP® 5
This article describes how ISPE GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized…
Risk Management for Avoidance of Drug Shortages
Shortages of essential medicines around the world have been an ongoing concern for patients…
Enabling Global Pharma Innovation: Delivering for Patients
ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
ICH Q13 and What Is Next for Continuous Manufacturing
The creation of a new ICH guidance document, Q13, International Council for Harmonisation of…
Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing
Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This…
A New Regulatory Approach to Drive Sustainable Medicines
To enable changes across the pharmaceutical industry, sustainability should be included alongside…
ISPE Briefs: New Guide Helps Maintain and Establish PPPQMS
ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality…
2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More
The 2022 ISPE Aseptic Conference Regulatory Panel session on 15 March was as always one of the…
Regulatory Landscape for Raw Materials: CMC Considerations
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients…
Streamlining Postapproval Submissions Using ICH Q12 & SCDM
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but…
Evolving China’s Regulatory System in Alignment with ICH
With the Chinese government initiating drug regulatory reform in 2015 and China joining the…
New EU AI Regulation and GAMP® 5
This article describes how ISPE GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized…
Risk Management for Avoidance of Drug Shortages
Shortages of essential medicines around the world have been an ongoing concern for patients…
Enabling Global Pharma Innovation: Delivering for Patients
ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
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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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