Do you trust your pills? Are you sure that nothing went wrong during production? Actually, you should be able to say yes, because medicinal products must be manufactured in such a way that they do not pose any risk to the patient through lack of safety, purity, quality or efficacy.
However, every step in the manufacturing process of medicinal products involves potential risks. Effective management, control and thus minimization of potential patient risks is only possible with the help of effective risk management.
The authoritative guideline for quality risk management, ICH Q9, has been revised. In today's editorial, you will find a summary of the most important changes in ICH Q9(R1).
