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

A comprehensive and practical introduction

This course will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

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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.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

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)

This course will cover:

Day 1
Day 2

Introduction to APIs

Terminology and acronyms
Globalisation
Introduction to the regulatory framework

Methods and equipment – Part 1

Chemical synthesis
Reactors
Isolation
Drying
Exercise: managing particle size

Methods and equipment – Part 2

Biological
Fermentation
Harvesting
Exercise: impurities

Good Manufacturing Practice (GMP)

Requirements
Regulations
EU
FDA
Exercise: similarities and differences

GMP requirements (continued)

Pharmaceutical Quality System
Validation and Qualification
Outsourcing
Exercise: specialist or generalist

Supply chain considerations

Falsified Medicines Directive (FMD)
Good Distribution Practice (GDP) for APIs
Exercise risk mitigation

Introduction and recap

Registration aspects of production and control

The registration process
The Common Technical Document (CTD)
Active substance/drug master files
Exercise: strategy

Laboratory controls

Good Quality Control Laboratory Practice (GQCLP)
Validation
Stability
Exercise: data Integrity

Process validation

Purpose of validation
General considerations
Exercise: critical attributes

Cleaning validation

Cleaning strategy
Key requirements
Residues
Exercise: purpose

API control packaging materials

What to consider
Data requirements
Extraction, interaction, migration and sorption
Toxicology
Exercise: environmental factors

Wrap up and Q&A

Paul Palmer
Paul R Palmer Ltd

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.

More details

Reviews of IPI's APIs in Focus: Understanding ICH, GMP and Supply Chain Excellence training course

I have accomplished a better understanding of API's after the two day webinar. Very good webinar which covers a good range of content, a little dense, so will need to refer back to it at some stage. Speakers were nice and accommodating. They clearly have a good understanding of the content they are presenting.

Jul 16 2025

Stephany Banglayan Ireland
Research and Development Analyst, Xeolas Pharmaceuticals