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A deviation is any departure from approved processes, procedures, instructions, specifications, or established standards.
In the pharmaceutical industry, deviations can occur during drug product development, manufacturing, labeling, packing, sampling, testing, storage, distribution, and other processes.
The deviation definition can vary slightly depending on the regulatory authority and requirements governing the company’s processes.
Some definitions of deviations according to different regulatory organizations and requirements are as follows.
International Organization for Standardization (ISO):
According to ISO 9001:2015, deviations in the context of quality management systems refer to the positive or negative effect resulting from a divergence from the expected or established standards.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):
In the ICH Q7 Good Manufacturing Practice (GMP) guide for active pharmaceutical ingredients, a deviation is defined as a departure from an approved instruction or an established standard.
Food and Drug Administration (FDA):
In the FDA’s guidance on quality management systems for the pharmaceutical industry and current Good Manufacturing Practice (cGMP) regulations, a deviation is described as a result that falls outside the expected range or fails to fulfill a specific requirement.
