Master the Essentials of Active Pharmaceutical Ingredient (API) Regulations with this Comprehensive Training Course (November 20-21, 2023)

Dublin, Nov. 02, 2023 (GLOBE NEWSWIRE) -- The "Understanding Active Pharmaceutical Ingredients (APIs) Training Course" conference has been added to's offering.

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 practices 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.

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


  • CPD: 6 hours for your records
  • Certificate of completion

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 runs from 09:30-17:00

The Understanding Active Pharmaceutical Ingredients (APIs) course will cover:

Day 1

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

Day 2

Introduction and recap of Day 1

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

For more information about this conference visit

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