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
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…
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…
iSpeak Blog
The Journey to Quality Management Maturity: ISPE European Conference keynote and ISPE APQ Program
Pharmaceutical and biopharmaceutical professionals at all levels of the industry gathered in…
Basic page
ISPE Regulatory Digest Q2 2023
ISPE is committed to fostering communications and interactions to advance common interests among the…
iSpeak Blog
Asia-Pacific Regulatory & Industry Views on Drug Shortage Prevention
The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory…
Product
ISPE Readiness Report Bundle
Report on ISPE Work to Support Establishment of the European Union Health Emergency Preparedness and…
Product
2023 ISPE Drug Shortages Prevention Model
Published: May 2023 Pages: 24 Special Pricing for Emerging Economies The ISPE Drug Shortages…
Video
Regulator & Industry Views on Drug Shortage Prevention
Learning Level: Intermediate Session Length: 1.5 hours The pressure points of the COVID-19 pandemic…
Guidance Documents
Active Pharmaceutical Ingredients (1)
Drug Shortages (3)
Project Management (1)
Quality Assurance (1)
Supply Chain Management (1)
Community Discussions
Community Discussions
Pharmaceutical Engineering Magazine Articles
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…
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Professional Development Training
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP ® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. Course Modules…
ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average…
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. CEUs are provided once…
GxPs for Leadership
This comprehensive course will equip you with the knowledge and skills to ensure GxP compliance and inspection readiness in the pharmaceutical industry. You will thoroughly understand regulatory requirements and learn about management's role in maintaining safety and quality. The course covers essential topics such as regulatory expectations, responsibilities in compliance, and consequences of non-compliance.