APIs in Focus: Understanding ICH, GMP (Good Manufacturing Practice) and Supply Chain Excellence Training Course

Course overview

An active pharmaceutical ingredient (API) or drug substance is the heart of every medicinal product, delivering the pharmacological activity or therapeutic effect needed to diagnose, treat, or prevent disease. Mastering the complexities of API manufacture is essential for ensuring quality, safety, and regulatory compliance in the pharmaceutical industry.

This course is designed to equip you with a clear and practical understanding of best practices and the regulatory landscape governing APIs. You’ll explore critical terminology, dive into the EU and USA regulatory frameworks, and gain insight into Good Manufacturing Practice (GMP) requirements, including controls and validation. The course also places strong emphasis on the International Council for Harmonisation (ICH) guidelines, which are increasingly central to global API regulation. You’ll learn how recent and upcoming ICH updates shape expectations for API development, manufacture, and quality assurance.

This course will also cover Good Distribution Practice (GDP) and will give you the tools to manage your supply chain effectively. With interactive exercises integrated throughout, you’ll cement your learning and leave ready to apply your knowledge in real-world settings. Whether you’re building your expertise or refreshing your understanding, this course provides an essential understanding of expectations for success in the development, purchase and manufacture of Active Pharmaceutical Ingredients.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

• Gain a comprehensive overview of the API regulatory framework and position yourself to navigate compliance challenges with confidence
• Enhance your understanding of the key terms used in API manufacture so you can communicate effectively and make informed decisions
• Recognise how Good Manufacturing Practices (GMP) apply to API synthesis and discover how to embed them seamlessly into your processes
• Understand the different approaches between small molecule and large molecule processing to stay ahead in a rapidly evolving industry
• Learn how to manage the risk associated with your supply chain and safeguard product quality from development to delivery

Who should attend

• New entrants to those individuals working in a GxP environment
• Quality management manufacturing specialists
• Regulatory compliance specialists
• Pharmaceutical technical professionals
• Pharmaceutical professionals looking to enhance their Continuous Professional Development (CPD)

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