Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most of the time are unplanned and for a purpose, some deviations are planned.

Deviations shall be properly addressed as they show an impact on the quality, safety, and efficacy of the medication, why we are repeating this sentence is, that most of the FDA warning letters are issued due to improper handling of deviations and now let us know the types of deviations and the criticality factor of a deviation.

Classification: 1. Planned Deviation 2. Unplanned Deviation

Planned Deviation: These are also called controlled deviations as they are intentionally done with prior planning. These are not unforeseen circumstances and are planned with proper documentation. reasons for planned deviations include process improvement and validation activities. These deviations are carefully handled so that there is no point of compromise on quality safety, and efficacy.

Un-Planned Deviations:  Unlike controlled deviations, these occur as a result of equipment breakdowns during the process or human errors like procedural deviations, out of specifications, deviating from the standard operating or testing procedures, documentation errors, power outage, in process failures, utility failures etc.

How to handle Unplanned deviations: Here is the outline of how deviations can be handled.

1. Identify the deviation
2. Investigate the cause
3. Perform Risk Assessment
4. Initiate CAPA ( Corrective Action , Preventive Action)
5. Document details of the deviation, investigation, risk assessment, and CAPA   as it is essential for regulatory compliance and quality assurance.
6. Review & Approval