SOP for Self Inspection in Pharmaceuticals Industry

This document details the procedure for Self-inspection and Self-inspection in manufacturing at XYZ Limited. It is the policy of XYZ Limited that written procedure shall be followed for self-inspection (Internal Audit).

It is a c-GMP and regulatory requirement that the company should have its internal audit system by which the company can assess the implementation of cGMP norms. An internal audit of the company is required during the routine functioning of the plant. 

At the time of conducting the internal audit of XYZ Limited. The frequency of conducting audits shall be twice a year.

>Standard Operating procedure Audit Checklist

RESPONSIBILITY

The following persons are responsible for the preparation and implementation of the SOP.

Executive - Corporate Quality Assurance:- To prepare and follow the SOP accordingly. Maintain the record as per SOP.

Director Production: - To ensure implementation of SOP.

Procedure of Self-Inspection 

5.1 Audit Team

5.1.1 Self-inspection (Internal Audit) shall be carried out twice a year by the self-inspection team in operational departments viz. Analytical Division, Quality Assurance, Quality Control, Warehouse, HRD, Production, and Engineering. It may also be carried out in case of repeated failures in the procedures, product recall, etc.

The external audit shall also be conducted at least once a year, by the external auditor(s).

The Quality Assurance Manager, Director of Production, and Quality Control Incharge shall constitute the Self Inspection team.

The self-inspection team shall include a minimum of two members (out of the following departments), excluding the audited department.

Head- Quality Assurance

Head- Quality Control

Head- Production

Head- Warehouse

Head- Engineering

Head- HRD

Any other person, if required

AUDIT PLAN/ SCHEDULE

Manager- Quality Assurance shall prepare an Audit plan/ Schedule every six months,  which shall be approved by Quality Assurance/ Director Production and to be distributed in advance to all the concerned department heads.

The audit plan shall declare the departments to be audited, the dates, and the team members from the self-inspection team, which shall conduct the inspection. Refer to appendix XYZSOP-034/FR-01 Self Inspection Plan / Schedule.

Any amendment in the self-inspection plan/ schedule shall be circulated to the auditee and auditors. 

The audit shall be conducted within the defined month of the schedule. If an audit is not conducted in the due time of schedule a justification is required in this regard.

AUDIT 

The self-inspection team shall take the help from ‘audit checklist’ as per XYZ/SOP-034/FR-03 Audit Checklist for Self Inspection for Warehouse(Appendix III), for Manufacturing as per XYZ/SOP-034/FR-04(Appendix IV), for Packaging as per XYZ/SOP-034/FR-05(Appendix V), for Quality Assurance as per XYZ/SOP-034/FR-06(Appendix VI), for Quality Control as per XYZ/SOP-034/FR-07(Appendix VII), for Engineering as per XYZ/SOP-034/FR-08(Appendix VIII) and for Human Resource Department as per XYZ/SOP-034/FR-09(Appendix IX), however, the inspection observations may not be limited to the checklist.

The audit team shall visit the functional area and inform the audited about the audit scope.

The audit team audits the work in the area using an audit checklist.

No routine work shall be kept on hold during the audit of the department.

The auditor shall provide all relevant documents (asked by an auditor) to the auditor at the time of audit within a reasonable time period.

The team during the inspection shall record the findings in the checklist itself and get the audited remarks for the findings on the checklist. All findings shall be categorized as non-conformance/ observation/ Area of Improvement.

The type of major Non-conformances are mentioned below but not limited to the following:

No written instructions.

Failure to follow instructions.

Unauthorized change in documents.

Obsolete document not removed.

Ineffective corrective actions.

Un-calibrated equipment/component.

Expired product/material in storage.

The logbook is not up to date.

The status of equipment/material is not mentioned.

No calibration record.

Findings that do not have a direct impact on product quality shall be termed as Observations.

Findings, where an auditor feels the scope of improvement shall be termed as Area of  Improvement.

Audit Report

A separate report shall be prepared for each individual department.

The auditor shall prepare the report on the SOP Audit Report categorizing the findings as non-conformance/ observation/ Area of Improvement.

All non-conformances/ observations/Areas of Improvement of the checklist shall be brought to the notice of the person having the responsibility of the respective department.

Corrective actions with a target implementation date shall be mentioned in the report in consultation with the Section Incharge of that department, the Director Production of the respective department.

Corporate Quality Assurance shall review and circulate the audit report to all concerned Sections Incharge for compliance and Director Production for necessary action.

Corrective Actions

The functional Head shall discuss the reports with other members of the department and plan to take corrective actions before the proposed date of implementation.

Non-conformances shall be handled as per SOP XYZ/SOP-015 out of Specification Results.

If any change is required to be implemented the corrective action, which may have an impact on the product quality, shall be handled as per SOP XYZSOP-029 Change Control.

After the implementation of corrective actions, the functional Section in Incharge, VP Technical,  shall submit the compliance report with adequate evidence to the Manager-Quality Assurance.

FOLLOW-UP and closeout 

Manager-Quality Assurance and Corporate Quality Assurance shall review the compliance report and evidence in support of the report.

Corporate Quality Assurance shall decide whether or not a re-audit is required or not of the concerned department. 

If a re-audit is required, the audit team shall re-audit the concerned department for the points raised during self-inspection.

If the auditing team is satisfied after re-audit, the follow-up report shall be submitted to Corporate Quality Assurance.

If Corporate Quality Assurance is satisfied with the report, it will make the remarks and close the audit report.

Storage of Documents

Finally approved document shall be stored in the documentation cell of the Quality Assurance Department.

The self-inspection record shall be preserved for a minimum of five years.

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