The Qualified Person should have a thorough knowledge of formulation and processing of the medicinal products they are asked to certify. This six-day (two part) module provides basic formulation principles, including preformulation studies, bioavailability considerations and the effect of excipients on physical and chemical stability. Each major product category is considered separately with respect to common formulations and processing techniques.
The course includes exercises on typical situations for the trainee QP to practice decision-making. Sessions on other key areas that a QP must understand including process validation and scale-up, facility design, utilities and sterilisation processes are included. Part one of the course includes a practical day to gain hands-on experience in the preparation and evaluation of some formulations.
The course includes exercises on typical situations for the trainee QP to practice decision-making. Sessions on other key areas that a QP must understand including process validation and scale-up, facility design, utilities and sterilisation processes are included. Part one of the course includes a practical day to gain hands-on experience in the preparation and evaluation of some formulations.
