QP Module: Active Pharmaceutical Ingredients

Course Overview

Revisions to EU GMPs mean that the responsibilities of the Qualified Person regarding Active Pharmaceuticals are wider than ever.

These include formally certifying that each Active Pharmaceutical Ingredient (API) is manufactured to GMP, knowledge of the API supply chain and complying with importation requirements as defined in the Falsified Medicines Directive.

This course includes both the technical aspects of manufacturing APIs and the requirements of Good Manufacturing Practice.

Suitability

An essential course for all those who expect to be taking the QP viva, it is also a valuable contribution to Continuing Professional Development for QPs who qualified some years ago. This is also suitable for those who require an understanding of the requirements for manufacturing APIs such as purchasing, manufacturing, supply chain or regulatory affairs staff.

Learning Outcomes

At the end of the course you will know:

• The role of the QP relevant to APIs

• The regulatory framework for the manufacture of APIs

• The requirements of the Falsified Medicines Directive and APIs

• How to use the European Guide to GMP for APIs

• The contents of a Drug Master File

• Methods and equipment used in synthesis

• Requirements for specifications, organic solvents and impurities

• Process and cleaning validation

• The control of packaging materials for an API