Understanding Active Pharmaceutical Ingredients (APIs)
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.
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Suitability - Who should attend?
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
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