What are Deviations?
There are many different contexts for use of the term “deviation”.
As per ICH Q7 GMP for Active Pharmaceutical Ingredients, a deviation is defined as a: “Departure from an approved instruction or established standard.”The terms used are not always the same for example, deviation, discrepancy, or nonconformity can be used.Handling of deviations is critical to patient safety and attracts enormous regulatory scrutiny. Deviation reports are normally reviewed during inspections, so the proper management of deviations and discrepancies is critical to any regulated organization.
In the context of the pharmaceutical industry the following is an example of a common deviation:
“The high-efficiency particulate air filters in your cleanroom have failed, resulting in possible contamination of one or more batches. This is a critical deviation with potentially serious consequences to patient safety”
In the life sciences, a deviation can arise at any point during a product’s lifecycle from
- Testing
- Manufacturing
- Product acceptance
- and Post-market surveillance.
