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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Mar 31, 2025
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Mar 28, 2025
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Mar 20, 2025
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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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Coming Soon and Recently Published ISPE Guidance Documents
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Pharmaceutical Compounding: A US FDA Perspective
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Mexico to Recognize GMP Certifications from North, South American Authorities
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UK Launches Monthly Bulletins on Device, Drug Safety
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Inside Africa's Plan to Produce Vaccines Locally
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Pharma Companies Developing Protein Interaction Prediction Model
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CDMO Building 2nd Manufacturing Facility in Portugal
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Flexible Robot can Automate Medical Device Manufacturing
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New Method May Improve CHO Efficiency
- How Digital Shadows Can Enhance Downstream Processing
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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