Deviation in pharmaceutical industry measure the difference between observed value and expected or normal value of a process or a product.

Deviation is categorized as planned deviation and unplanned deviation

Planned deviation:

Planned deviation means pre approved deviation, we know before it occurs. Planned deviation shall be approved before execution. For example, timeline extension for a process completion.


Unplanned deviation:

Unplanned can be defined as departure from written procedure or previously approved process. It may the unexpected or 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 also be categorized as Minor, Major and Critical based on the impact on the quality

Minor Deviation:

When the deviation does not affect the safety, identity, strength and purity 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. For example, room condition outside the limt.


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. For example, sieving is not perform right way, addition order is not correct etc.


Critical Deviation:  

A substantial potential  quality attribute, aameter, 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. For example, API mixup, wrong API dispensed etc.


Difference between Planned deviation and Unplanned deviation

Planned deviation

  • Planned deviation is the preapproved deviation.
  • Planned deviation shall be approved before execution.
  • No Route cause analysis or corrective action preventive action (CAPA) is required for planned deviation as parameters are intentionally deviated.
  • Example of planned Deviation: Use raw material for unapproved vendor, Change in batch size, Change in equipment, release of material with limited test etc.


Unplanned Deviation

  • Unplanned deviation is that deviation which occurs during the execution of the plan.
  • Unplanned deviation is never approved before the execution.
  • Example of unplanned Deviation: Human error e.g: wrong batch number, Dilution error, wrong solution preparation, Material is not charged properly. 
  • Route cause analysis and corrective action preventive action (CAPA) required.


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