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.
CPD Hours: 12
Course Content
- Day 1
- Introduction to APIs
- Methods and equipment - Part 1
- Methods and equipment - Part 2
- Good Manufacturing Practice (GMP)
- GMP requirements (continued)
- Supply chain considerations
- Day 2
- Introduction and recap
- Registration aspects of production and control
- Laboratory controls
- Process validation
- Cleaning validation
- API control packaging materials
- Wrap up and Q&A
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
