Drug Manufacturing and Quality Systems

This course will give students an understanding of drug production, with regard to formulation technology and the systems that ensure that drugs of satisfactory quality are produced.

Knowledge

After completing the course, the student should have

• in-depth knowledge of quality assurance in pharmaceutical handling.
• in-depth knowledge of quality requirements, quality assurance and control of key steps in the development and production of pharmaceuticals.
• knowledge of storage and distribution of pharmaceuticals.
• knowledge of validation processes for laboratory buildings, medical equipment and manufacturing processes.
• knowledge of the structure, roles and division of responsibilities in GMP.

Skills

After completing the course, the student can

• propose strategies for the formulation of new radiopharmaceuticals.
• link different parts of a batch production to relevant chapters in GMP.
• contribute to documenting drug quality to regulatory authorities.
• contribute to developing quality systems for drugs.
• handle production technical deviations according to GMP.

General competence

After completing the course, the student has an understanding of

• characteristic aspects of the manufacture of radiopharmaceuticals with a short physical half-life.
• how consistent quality work contributes to patient safety in the pharmaceutical field.
• which quality aspects must be taken care of before releasing a drug for clinical use.

Lectures and assignments, mandatory attendance at one hour group work and four lectures.