Non-Conformity Reports (NCRs) SOP
1.0
PURPOSE:
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1.1. To
establish a procedure for identification of non-conformances, its evaluation
and elimination as well.
2.1. This procedure applies to
the non-conformities identified in products, processes and services of _________Pharmaceuticals.
3.1. NCR Originator
3.2. Concerned Department Head
3.3. Auditor(s)
3.4. QA Manager
3.5. QA Officer
4.0 PRINCIPAL:
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On the basis of nature of non-conformity, NCR has
been categorized into following:
4.1. Critical: A deficiency leading to harmful effects to
human/animals.
4.2. Major:
A deficiency in which the product is Out of Specifications/Sub-standard.
4.3. Other
/ Minor: A deficiency which is neither critical nor major however it is a
departure from GMP.
5.0
PROCEDURE:
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5.1. Non-Conformity
Report (F-07-009) can be raised as a result of:
5.1.1. Routine
Inspection/Testing
5.1.2. Customer
Complaint
5.1.3. Internal Audit
5.1.4. GMP Audit
5.1.5. Self inspection
5.1.6. Process
Deviation.
5.2. The Person
raising NCR follows this procedure in processing the Report.
5.2.1. Enter own name,
designation & Sign (Optional)
5.2.2. Enter date of
Report and get it a specific number from QA log of NCR .
5.2.3. Tick the
appropriate of non-compliance based on nature of non-conformity.
5.2.4. Write/mention
the description of Non-Conformity in column of description.
5.2.5. The originator
will hand over the NCR to QA Manager.
5.2.6. QA Manager will
get receipt from responsible person/official.
5.2.7. The responsible
person/official will take appropriate corrective and preventive actions (CAPA)
and document it in relevant column.
5.2.8. QA Official
will follow up to verify the status on target date.
5.2.9. If NCR is found
complied, QA Officer closes it otherwise will inform Director for further
follow up.
5.2.10. When NCR is
found complied it will be closed out and documented appropriately.
5.3. Root Cause
and Result of Investigation:
5.3.1. The Department
Head (where non-conformance was identified) review the NCR and determine the
course of action to be followed in consultation with area Incharge. Description
of cause and investigation are entered, then corrective action and its
implementation is enforced.
5.4. Corrective
Action:
5.4.1. The concerned
department head is responsible to take corrective actions for identified non
conformity & forward completed NCR with support documents; report etc to QA
Manager who after review closes it.
5.5. Close Out:
5.5.1. The NCR is
closed out after corrective action follow up & review by Quality Assurance
Manager & Director.
EVIDENCES OF RECORDS & REFERENCES
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F-07-009
Log of NCRs
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FORMAL KPIs
(Key Performance Indicators)
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No. of NCRs raised and then closed
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GENERAL RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Non-conformity has not been
reported/investigated
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Root cause will not be identified to avoid
reoccurrence
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Always follow SOP for NCRs raising
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QA Officer
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