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.
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
Course Content
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
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
Course Provider
Paul Palmer,
Paul R Palmer LtdPaul 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.
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)
