Active Pharmaceutical Ingredients

£1070 + VAT

Dates for 2009 to be published shortly

European union legislation now requires that all active pharmaceutical ingredients (APIs) going into drugs sold in Europe meet Good Manufacturing Practices (GMPs) as of October 2005.

This  course deals with the key issues associated with both the chemical and biological manufacturing of API materials using real life case studies.

The course is aimed at intending and existing Qualified Persons and is based on the requirements of the QP Study Guide 2000. It will also be of great value to any pharmaceutical professional working in QA, QC, Medical, production and regulatory environments.

Course Content:

• Standards and guidelines for APIs and excipients
• Basic concept of API Good Manufacturing Practice
• Part 2 EU GMP guide: GMP for APIs
• Commonly used manufacturing methods and techniques
• Process and cleaning validation requirements for APIs
• Methods and techniques used in biological manufacture
• Automated and semi-automated processing requirements
• Licence requirements and Drug Master Files

To book a training course, please download the booking form, complete and email to bookings@rssl.com