Types of Deviations in Pharmaceutical industry

Deviation is categorized as planned deviation and unplanned deviation:

Planned deviation:

  Planned deviation mean pre approved deviation. Planned deviation shall be approved before execution.

  planned deviations are those the procedure are already planned and we know before they occur.

Unplanned deviation :

Unplanned can be defined as departure from written procedure . It may the uncontrolled event during performing the  procedure or operation any stage of manufacturing, packaging, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.

  

Deviation can be categorized as Minor, Major and Critical based on the impact on the quality

Minor Deviation:

When the deviation does not affect or minimum impact on  quality attribute, or critical process parameter, or an equipment or instrument critical for process or control, it would be categorized as Minor.

Major Deviation:

Moderately impact on quality attribute, a critical process parameter, an equipment or instrument critical for process or control, the deviation is categorized as Major deviation

Critical Deviation:  

a substantial potential  quality attribute, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel or environment) is highly probable, including life threatening situation, the deviation is categorized as Critical.

 You can also refer Difference between planned and unplanned Deviation .