Flow chart for Deviation control Procedure in Pharmaceutical Industry

Identification of deviation Issuance of the deviation control form from QA department (with unique deviation number) Fill up the deviation control form with proper justification by the concern department Comments of other department (If any impact on their system due to deviation) Review and investigation of the deviation  by QA designee (Categorize the deviation) Evaluation of deviation by Head QA Approval or rejection of the deviation Proper corrective and preventive action(CAPA) based  on the investigation and route cause analysis Implementation of Corrective and preventive action(CAPA) if required Closing of deviation

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.

 

Related Post:

Deviation Management in Pharmaceutical Industry

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

Difference between Planned deviation and Unplanned deviation

Planned deviation:

·                Planned deviation is the preapproved deviation

·                Planned deviation shall be the approved before execution Planned deviation are those the procedure is already planned and we know the

·                Planned deviation is the preapproved deviation.

·                Planned deviation shall be approved before execution.

·               Planned deviations are those the procedure is already planned and we know before it happens.

·               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

- change in solvent during R & D trial

-Change in packing quantity

-release of material with limited test  

Unplanned Deviation:

·               Unplanned deviation is that deviation which occurs during the execution of the plan.

·           Unplanned deviation is never approved before the execution.

·           We don’t know where when how it happens; It   happens at any stage of manufacturing, packaging, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.

·           Example of unplanned Deviation:

-Human error e.g: wrong batch number, Dilution error, wrong solution preparation, Material is not charged properly. 

-Calibration is due

-Output beyond the validated range.

-Training is not given as per schedule

- Route cause analysis and corrective action preventive action (CAPA) are required.

Related Post:

Deviation Management in the Pharmaceutical Industry

Importance of Deviation in Pharmaceutical Industry

Types of Deviation in Pharmaceutical Industry

Difference between deviation and incident

Deviation Formats/Template in Pharmaceutical Industry

 

Importance(Requirement) of Deviation in Pharmaceutical industry

Following are the reason why deviation should documented in Pharmaceutical industry:

-To document the any abnormal activity happen in plan, as it can be reference for the future.
 

-To reduce the adverse impact on the quality of the product. 

-To prevent the re occurrence of the deviation. 

-Repeated deviation can be identified, If based on the repeat deviation any requirement of change in present situation it can be identified and improved (E.g. : change in equipment of any part of the equipment).

-Route cause analysis (RCA) can be find by the proper identification and documentation of deviation. 

-Proper Corrective action and preventive action(CAPA) can be taken by finding the exact reason of the deviation. 

-To identify the risk during the manufacturing activity accordingly risk analysis can be performed 

-By proper risk analysis risk can be reduced.

Handling of unplanned deviation in Pharma (SOP of unplanned deviation control)

Purpose:

The purpose of the SOP is the describe the SOP for reporting, handling, investigate and closing the documentation of the deviation.

Scope:

The procedure is applicable for all concerned department and activity related to manufacturing facility and GMP.

Responsibility:

Concern department: Identify the deviation and initiation of deviation with proper details and justification

Concern department Head: Review the deviation details properly

QA designee: Investigation and review of the all parameters and activity involved in deviation.

QA Head : Review the all details of deviation and closing of deviation with proper justification.

Material and equipment:

Not applicable 

Procedure:

- Report all deviation immediately to responsible supervisor of the concern department.

- To initiate the deviation the concern department person shall be discuss with their head and after discussion they shall give the requisition to QA department for issuance of the deviation control Form

- QA person shall issue the deviation control form controlled stamp along with sign and date.

- QA person shall enter the details in deviation control register er.QA person shall assign the unique deviation number on each deviation.

- After issuance of the deviation control form concern person shall fill all the all the details as mention in deviation control form with proper justification.

- Deviation shall be categorized as Minor, Major or Critical deviation based on the impact on the quality of the product.

- Comment shall be taken of impact department for any activity or documents are impacted due to the deviation. If any documents activity is impacted proper planning for action shall be required.

- QA designee shall review the deviation details and comment on the deviation with sign.

- Head QA shall evaluate the details and QA and designee and concern person investigate the all activity and data related to the deviation.
- Route cause analysis(RCA) will be performed if required.

- After proper investigation corrective action preventive action (CAPA) shall be taken and all activity shall be preformed to complete the corrective action preventive action (CAPA)

- After review and implementation of all activity QA head shall be closed the deviation.
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Deviation format/Templates in Pharmaceutical industry

Logo of company	Company Name Deviation control Form	Deviation No:_____________ Date             :_____________
Name of the department:
Details of deviation:
Justification :
Initiated by:                                                                         Reviewed By: (Concern Dept Designee: )                                               (Concern Dept Head: )
Page No: 01 of 03

Logo of company	Company Name Deviation control Form	Deviation No:_____________ Date             :_____________
Impact on other Department : Department Name: Comment: Department name: Comment:
Comment Of QA Designee:
Comments of Head QA: Approved/Reject
Page No: 02 of 03

Logo of company	Company Name Deviation control Form	Deviation No:_____________ Date             :_____________
Corrective preventive action (CAPA):
Closing Of the deviation:
Closed By: Date Closing:
Page No: 03 of 03