In the pharmaceutical industry, a deviation is any unwanted event that differs from the approved processes, procedures, instructions, specifications, or established standards. Deviations can occur during the manufacturing, packing, sampling, and testing of drug products. There are three types of deviations: critical, major, and minor. A critical deviation affects the quality of a critical process parameter, equipment, or instrument or has an immediate patient safety risk or life-threatening situation. A major deviation impacts a product’s quality, safety, or efficacy but may not have a direct impact on patients. A minor deviation affects a utility, equipment, material, component, or documentation but does not affect product quality or the physical state of the product or its labeling.
Deviations can be planned or unplanned. Planned deviations are pre-approved temporary deviations from an existing protocol or process. They cover a specific time period or a definite number of batches. These deviations are undertaken by an organization to avoid a problematic situation. Planned deviations are organized in such a manner that they do not affect the safety and efficacy of products. Examples of planned deviations in the pharmaceutical industry include a change in batch size due to reduced availability of raw materials or a change in supplier for excipients.
Unplanned deviations are non-compliances with designed protocols or systems that occur at any stage of a products lifecycle, including manufacturing, testing, holding, packaging, and storage. They can be caused by human error, utility failure, equipment/instrumentation breakdowns, or malfunctions. Examples of unplanned deviations in the pharmaceutical industry include interruption of power supply resulting in equipment breakdown or an accident at the site due to human error.
For compliance with Good Manufacturing Practice (GMP) and the sake of continuous improvement, any deviation from established procedures needs to be documented. FDA § 211.192 requires a thorough investigation of any deviation, including documentation of conclusions and follow-up. The Quality Management System should ensure that deviations from established procedures are identified and recorded. Incidents that could affect the quality or the reliability of records or tests should be investigated and resolved.
