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ISPE’s Drug Shortages Initiative focuses on the technical, scientific, manufacturing, quality and compliance issues associated with a company’s supply chain and related to its ability to source, manufacture and distribute products that have resulted in drug shortages.
Any effort to effectively address the complex and multi-faceted issues contributing to drug shortages requires close technical collaboration and clear communication between the pharmaceutical industry and global health authorities. For nearly a decade, ISPE has been instrumental in facilitating communication between the different sectors of the pharmaceutical industry and global health authorities related to drug shortages.
iSpeak Blog
Streamlining the Path to Drug Supply Resilience in the US
Finding the Way Forward Together Everyone can agree patients need reliable access to their medicines…
iSpeak Blog
Crisis Management and Partnership with US Food and Drug Administration (US FDA): North Cove’s Recovery After Hurricane Helene
In September 2024, Hurricane Helene, a category 4 hurricane, hit the Baxter North Cove facility in…
Video
Strengthening Drug Shortage Frameworks: Global Perspectives and Regional Action
Strengthening Drug Shortage Frameworks: Global Perspectives and Regional Action Complimentary…
PE Articles
Critical Deficiencies Undermine QRM Effectiveness
With nearly 2,000 drugs currently in shortage across the UK—a staggering increase from 1,608 just…
iSpeak Blog
A Holistic Mindset is Key to Supply Resiliency
Supply resiliency for pharmaceutical manufacturing has been a topic of increasing interest to global…
Basic page
ISPE Regulatory Digest Q1 2024
ISPE is committed to fostering communications and interactions to advance common interests among the…
iSpeak Blog
Understanding the Challenges in Drug Shortages
Carla J. Lundi, US Food and Drug Administration (FDA) Senior Consumer Safety Officer, Division of…
Video
Mastering Controlled Temperature Chambers: Qualification, Mapping, and Monitoring in GxP Environments
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour This webinar offers a…
News
Scrip Asks…What Does 2024 Hold for Biopharma?
ISPE President and CEO Thomas Hartman calls attention to the importance of addressing drug shortages…
News
Manufacturing and Supply Chain: Making Space Between a Rock and a Hard Place
Leaders from the pharmaceutical industry are providing suggestions to their peers and colleagues, in…
PE Articles
Risk Management for Avoidance of Drug Shortages
Shortages of essential medicines around the world have been an ongoing concern for patients…
PE Articles
ISPE Briefs: ISPE Initiatives Provide Guidance on Medicines Supply
ISPE task teams created reports and a model to examine the challenges surrounding drug shortages…
Guidance Documents
Active Pharmaceutical Ingredients (1)
Drug Shortages (3)
Project Management (1)
Quality Assurance (1)
Supply Chain Management (1)
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Pharmaceutical Engineering Magazine Articles
Critical Deficiencies Undermine QRM Effectiveness
With nearly 2,000 drugs currently in shortage across the UK—a staggering increase from 1,608 just…
Risk Management for Avoidance of Drug Shortages
Shortages of essential medicines around the world have been an ongoing concern for patients…
ISPE Briefs: ISPE Initiatives Provide Guidance on Medicines Supply
ISPE task teams created reports and a model to examine the challenges surrounding drug shortages…
Business Continuity Planning to Prevent Drug Shortages
As noted in the ISPE Drug Shortages Prevention Plan, International Society for Pharmaceutical…
Drug Shortages: a 30,000 Ft View: Business Continuity Planning for Preventing Drug Shortages
As noted in the ISPE Drug Shortages Prevention Plan, International Society for Pharmaceutical…
Engage with Health Authorities to Mitigate & Prevent Drug Shortages
When faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and…
Webinars
Featured Conferences
Special Initiatives
iSpeak Blog Posts
Professional Development Training
Hands-On C&Q/PV/ATMP
The course will cover qualification and process validation, from EU and US perspectives, considering both small and large molecule aspects, plus it will include a half day to consider qualification and process validation for ATMPs.
Quality: Miscellaneous
High-level overview of quality event management principles and practices. Part 3 of the ISPE Quality Training Series Quality: Events Quality: Documentation Quality: Miscellaneous Quality: Miscellaneous is the third and final course in ISPE’s comprehensive three‑part Quality Training Series, following Quality: Events and Quality: Documentation. While the earlier courses focus on the identification, management, and documentation of quality events within a GMP environment, this course broadens the perspective to address a set of additional quality system elements essential to maintaining a…
Quality Control Analytical Laboratory Testing
Quality Control Analytical Lab Testing Fundamentals provides a foundational introduction to the essential laboratory practices that underpin Quality Control (QC) operations in pharmaceutical and biopharmaceutical environments. Designed for those new to QC testing or seeking to strengthen their understanding of core analytical principles, this course explores not only what happens in the QC laboratory, but why these practices are vital for ensuring product quality, regulatory compliance, and ultimately, patient safety. Through practical examples and structured guidance, learners will gain…
GAMP® AI Basic Principles Training Course – 2-Day
GAMP® AI guidance provides a pragmatic and effective framework for achieving AI-enabled computerized systems that are fit for intended use and aligned with current regulatory expectations. This course introduces participants to the requirements for AI-enabled computerized systems and internationally recognized methods of meeting those requirements.
Quality: Documentation
High-level overview of quality event management principles and practices. Part 2 of the ISPE Quality Training Series Quality: Events Quality: Documentation Quality: Miscellaneous This course provides a high-level overview of essential quality documentation practices and SOPs. Rather than focusing solely on completing individual forms, this course explains why elements such as SOPs, batch records, change control forms, and supporting documentation are critical to a robust pharmaceutical quality system. You’ll learn the key principles behind effective document creation, control, and lifecycle…