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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