SOP FOR non conformance reporting.

OBJECTIVE:

To lay down a procedure for non conformance reporting.

SCOPE:

This SOP shall be applicable for non conformance reporting to department head.

REFERENCE:

In-house

RESPONSIBILITY:

Concerned Department Personnel: To report the non conformance as per SOP.
QA Personnel: To investigate the non conformance in conjugation with concerned department personnel.

DISTRIBUTION:

All Departments

ABBREVATIONS & DEFINATIONS:

SOP: Standard Operating Procedure

QA: Quality Assurance

HOD: Head of department

Non conformance

Non conformance is an unplanned event that occurs in non-compliance with the designed systems or procedures at any stage of the receipt, storage, manufacturing and analysis of a drug product.

PROCEDURE:

Non conformance are classified as

Quality impacting

Quality non-impacting

Quality impacting non conformances

Quality impacting non conformance is occurrence / error during execution of any activity which will affect the quality, purity and strength of a product.

Quality non impacting non conformances

Quality non-impacting are occurrences during execution of any activity, which may have no impact directly on the quality, purity, and strength or a drug product.

Address the non conformance in the non conformance report Form No as “CN/NC/13XX”.

CN : Company name

NC : Non conformance

13 : Last digits of year

XX : Serial Number

Initiate non conformance report and fill in the details. Write investigation details and suggestive corrective action in conjugation with QA department.

Forward the non conformance report to department head for comments and signature.

Forward non conformance report to plant manager for comments and signature.

Forward the non conformance report to QA manager for comments and signature.

The QA department will keep the non conformance report for record and future reference.

FREQUENCY:

As and when any non conformance found.

ANNEXURE:

Annexure 1- Non Conformance Report

Annexure 1- Non Conformance Report

Non conformance Report Number: Department:

Sr. No.	Observations	Remark
1.
2.
3.	Date
4.	Description of Non Conformance
5.	Investigation

Suggestive corrective action:

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