Pharma information Zone: Difference between Deviation and Incident

Deviation and incident both are phenomena that happen in the pharmaceutical industry. There is a minor difference in the incident and the deviation in the pharmaceutical industry.

Definition of deviation:

Deviation is defined as departure or from written down instruction or predetermined specifications or procedures during operation and performing any activity.

E.g: of deviation is material is not charged proper quantity

In the pharmaceutical industry, there are so many documents example: standard operating procedures, Specifications, Test methods, Methods of analysis. We need to follow the instruction written in the documents. If we are not following the procedure or instructions written in documents. They may not follow the instructions stepwise or they may follow the difference that mentioned is known as the Deviation.

It may impact directly or indirectly the quality of the product or may not impact the quality of the product.

Definition of Incident:

Incidence is an abnormal occurrence that is not defined in the approved documents or standard operating procedure. It may impact or may not impact the quality of the product

Incidence is an event which is not the part of SOP but that is against The C-GMP which may affect the quality of product r may be not.

E.G: Spillage of material.

In both cases Corrective action and preventive action will be taken based on the proper Route cause analysis if required.

Following are the examples and differences between deviations and incident

Example of Deviation:

Here an example of the deviation.

1. As per standard operating procedure Material shall be charged in reactor by using proper scoops. But the personnel charge the material directly into the reactor without using the scoop. It comes under the deviation category.

If the material falls down during the direct charging and the required quantity is not charged it may impact the quality of the product. There may be a chance of contamination which also impacts the quality of the product.

Example of incident:

The personnel charging the material is as mentioned in the procedure. During the charging of the material, there is spillage of material. This phenomenon comes under the incidence.

Difference between Deviation and Incident:

The main difference between the deviations and incidence is following

In case of the deviation, we are already instructed by standard operating procedure or the plant log sheet of the method of analysis or any other document how to perform the activity and person not perform the activity as mentioned.

An incident is an abnormal phenomenon that happens which is not mentioned or documented.

Similarities between deviation and Incident:

Deviation incidents are both phenomena that happened in the pharmaceutical industry which may impact the quality or may not be impacted on quality. Which is decided by the evaluation of the deviation or incident.

Importance of deviation in Pharmaceutical Industry

Types of Deviation in the Pharmaceutical Industry

Deviation Formats/Template in Pharmaceutical Industry

SOP on the handling of Unplanned Deviation

Example of Deviation

Deviation in the pharmaceuticals industry

Difference between planned and unplanned deviation