What is risk?

A probability or threat of damage, injury, liability, loss, or any other negative occurrence that is caused by external or internal vulnerabilities, and that may be avoided through preemptive action.

For Pharmaceutical Product safety there are several directive and guideline to measure safety from the start to the end, which includes testing, manufacturing, transporting, procuring, storing and up to the last point where the drug is given to the patient.

According to Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use in Chapter 1.5. Quality risk management: “Quality risk management should ensure that the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient.” Wholesalers quality systems must include assessment, control, communication and review of risks to the quality of medicinal products throughout the supply chain

But going a little bit more deeply, ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guideline Q9 on quality risk management says: “Risk management can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labelling materials.”

At last but not least there are safety measures on us – the patient – when taking medicines. There is always a risk! But we cannot make a decision on the level of risk when given the prescription. The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing all aspects of risk management of human medicines, including: the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account; design and evaluation of post-authorisation safety studies and pharmacovigilance audit. These measures are for our safety. Risk assessments are crucial in our life when dealing with medicine in any way.