Understanding Active Pharmaceutical Ingredients (APIs) 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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Format: Live online
CPD: 12 hours for your records
Certificate of completion

Course overview

An active pharmaceutical ingredient (API) or drug substance is any substance or mixture of substances intended to be used in the manufacture of a medicinal product, which is intended to furnish pharmacological activity, or have another direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or affect the structure and function of the body.

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It 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. Practical exercises will form part of the course to aid the learning process.

This is an essential and valuable introduction to the manufacture of APIs.

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
Enhance your understanding of the key terms used in API manufacture
Recognise how Good Manufacturing Practices (GMP) apply to API synthesis
Understand the different approaches between small molecule and large molecule processing
Learn how to manage the risk associated with your supply chain

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.

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