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.
CPD Hours: 12
Course Content
- Day 1
- Introduction to APIs
- Methods and equipment - Part 1
- Methods and equipment - Part 2
- Good Manufacturing Practice (GMP)
- GMP requirements (continued)
- Supply chain considerations
- Day 2
- Introduction and recap
- Registration aspects of production and control
- Laboratory controls
- Process validation
- Cleaning validation
- API control packaging materials
- Wrap up and Q&A
Speakers
Farah Nadeem
Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.
Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.
In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.
Aneta Jell
Aneta Jell is a seasoned Quality Assurance professional with over 20 years of experience
across manufacturing, contract operations, and quality leadership in the pharmaceutical
industry. Currently serving as Quality and training manager at PaulPalmer limited she
oversees global contract manufacturing quality, ensuring GxP compliance, regulatory
alignment, and supply chain integrity. Her expertise spans GMP, ISO 9001, ISO 17025, and
QMS administration, with proven strength in audits, CAPA, deviations, and technical
agreements. A qualified QMS lead auditor with bilingual proficiency in English and Slovak,
Aneta is recognised for driving continuous improvement, fostering compliance culture, and
leading high-performing quality and HSE teams.
Who Should Attend
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)
