Standard Operating Procedure of Non-Conformity Reports (NCRs) of Pharmaceuticals is describe in this post.
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1. Purpose:
1.1. To establish a procedure for identification of non-conformances, its evaluation and elimination as well.
2. Scope:
2.1. This procedure applies to the non-conformities identified in products, processes and services of Pharmaceuticals.
3. Responsibilities:
3.1. NCR Originator
3.2. Concerned Department Head
3.3. Auditor(s)
3.4. QA Manager
3.5. QA Officer
4. Principal:
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. Procedure:
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.
6. QA department maintains documented record of non-conformances in their department.
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