Active Pharmaceutical Ingredients - QP Module

Course Overview

The Qualified Person must understand the influence of manufacturing pathways and associated physical and physico chemical attributes of both active pharmaceutical ingredients and major excipients on the quality of the finished dosage form.

QP responsibilities also 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.

This course includes the following topics:

Day 1

• Methods and equipment including virtual tour of chemical facilities
• Methods and equipment for Bio APIs
• GMP requirements for API’s-Eudralex Vol 4
• GMP requirements FMD and GDP
• GMP requirements ICH and impurities

Day 2

• Registration aspects including QP declaration exercise
• Laboratory controls
• Process validation overview
• Cleaning validation overview
• Supply chain and QP responsibilities
• The control of API packaging materials
• API audit situations

Prerequisites

This is 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.

Additional information

Teaching method: online/classroom