In general, your organization will encounter two types of deviations:
– Planned Deviations
– Unplanned Deviations
1.Planned Deviations:
=> Planned deviations are temporary deviations from an existing protocol or process that have been pre-approved.
=> They are limited to a specific time period or a number of batches. Your organization makes these changes to avoid a potentially hazardous situation.
=> Deviations are planned in such a way that they do not compromise the safety and efficacy of your products.
Examples of planned deviations in the pharmaceutical industry:
=> Change in batch size due to reduced availability of raw materials
=> Change in batch size for a specified number of batches
=> Change in supplier for excipients
2.Unplanned Deviations:
=> Unplanned deviations are non-compliances with your designed protocols or systems that occur at any stage of a product’s lifecycle, including manufacturing, testing, holding, packaging, and storage.
=> Unplanned deviations are also referred to as unplanned events, uncontrolled events, or incidents.
=> They can be caused by human error, utility failure, equipment/instrumentation breakdowns, or malfunctions.
Examples of unplanned deviations in the pharmaceutical industry:
=> Interruption of power supply resulting in equipment breakdown
=> Accident at the site due to human error
=> Disruption of utility services