STANDARD OPERATING PROCEDURE

DEPARTEMNT QUALITY ASSURANCE

Title Self-Inspection
Doc. No. Revision No. Issue Date Effective Date Next Revision Date
QA-G-SOP-009 00
Replaces. N/A
Prepared By Reviewed By Approved By Authorized By
Name Kiran Tauqeer Ali Raza Sawar Khan Sarah Shaikh
Designation QA Executive AM Quality Assurance QA Manager GM Quality Operations
Signature
Date
CONFIDENTIAL- This document is the property of Rotex Pharma Pvt. Ltd. and should not be shared, reproduced or duplicated without QA consent.

Table of Contents
1 PURPOSE...........................................................................................................................................................2
2 SCOPE................................................................................................................................................................2
3 ROLE & RESPONSIBILITIES..........................................................................................................................2
4 FREQUENCY OF SELF INSPECTION............................................................................................................2
5 PROCEDURE.....................................................................................................................................................2
5.1 Self-inspection Schedule:............................................................................................................................2
5.2 Schedule of self-inspection shall cover the following minimum general activities:..................................3
5.3 Team Selection:..........................................................................................................................................3
5.4 Conduction of Self-Inspection:...................................................................................................................3
5.5 Recording and Reporting of Findings.........................................................................................................3
5.5.1 The findings should contain the following information:....................................................................3
5.6 Findings Classification................................................................................................................................4
5.6.1 Critical:...............................................................................................................................................4
5.6.2 Major:..................................................................................................................................................4
5.6.3 Minor:.................................................................................................................................................4
6 CAPA/COMPLIANCE AND RESPONSIBILITY............................................................................................4
7 FOLLOW-UP ACTION.....................................................................................................................................4
8 FLOW CHART...................................................................................................................................................5
9 CHANGE HISTORY..........................................................................................................................................6
10 RELATED DOCUMENTS................................................................................................................................6
11 REFERENCE......................................................................................................................................................6
12 DISTRIBUTION LIST.......................................................................................................................................6

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 STANDARD OPERATING PROCEDURE
DEPARTEMNT QUALITY ASSURANCE
Title Self-Inspection
Doc. No. Revision No. Issue Date Effective Date Next Revision Date
QA-G-SOP-009 00
Replaces. N/A
Prepared By Reviewed By Approved By Authorized By
Name Kiran Tauqeer Ali Raza Sawar Khan Sarah Shaikh
Designation QA Executive AM Quality Assurance QA Manager GM Quality Operations
Signature
Date
CONFIDENTIAL- This document is the property of Rotex Pharma Pvt. Ltd. and should not be shared, reproduced or duplicated without QA consent.
1 PURPOSE
The Purpose of this SOP is to define the activities, requirements, decision and responsibilities for the self-
inspection in a standardized, systematic and effective manner for the evaluation of compliance status of
Rotex Pharmaceutical (PVT) Ltd.
2 SCOPE
2.1 To promote the awareness of Quality and GMP within the department.
2.2 To identify and correct non-conformities.
2.3 To detect operational deviations and regulatory compliance deficiencies.
2.4 To assure the effectiveness and to support continuous improvement of compliance.
3 ROLE & RESPONSIBILITIES

Roles Responsibilities
Self-Inspection Team To conduct self-inspection, record and report findings
Department To create and populate a self-inspection schedule which identifies areas and
Manager/Designate system to be inspected.
To determine Self inspection team.
In conjunction with the QA manager ensure that self-inspection processes are In
Department Manager
Place and In Use.
To prepare and implement CAPAs
For ensuring that schedule of inspection and system for compliance is effective.
In conjunction with the Department manager ensure that self-inspection processes
QA Manager
are In Place and In Use.
To approve changes to an agreed CAPA.

4 FREQUENCY OF SELF INSPECTION

Frequency of self-inspection should be bi-annually.
5 PROCEDURE
5.1 Self-inspection Schedule:
5.1.1 The Department Manager/Designate will prepare self- inspection schedule for next year.
5.1.2 The schedule should identify area, systems/activities that are to be inspected according to
relevant month.

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 STANDARD OPERATING PROCEDURE
DEPARTEMNT QUALITY ASSURANCE
Title Self-Inspection
Doc. No. Revision No. Issue Date Effective Date Next Revision Date
QA-G-SOP-009 00
Replaces. N/A
Prepared By Reviewed By Approved By Authorized By
Name Kiran Tauqeer Ali Raza Sawar Khan Sarah Shaikh
Designation QA Executive AM Quality Assurance QA Manager GM Quality Operations
Signature
Date
CONFIDENTIAL- This document is the property of Rotex Pharma Pvt. Ltd. and should not be shared, reproduced or duplicated without QA consent.
5.2 Schedule of self-inspection shall cover the following minimum general activities:
5.2.1 Housekeeping and cleanliness.
5.2.2 In-place and in-use status of Standard operating procedures
5.2.3 Compliance with standard methods.
5.2.4 Equipment/Instrument maintenance & calibration.
5.2.5 Compliance with HSE & GMP requirements.
5.2.6 Quality assurance representative will review the schedule.
5.2.7 Department Manager will approve and maintain the self-inspection schedule.
5.2.8 Department Manager will communicate the self -inspection schedule to all department
personnel involved in self-inspection and to QA via hard copy.
5.3 Team Selection:
5.3.1 The department manager will select the self-inspection team and team leader.
5.3.2 The self-inspection team leader must be trained and must have 3-5 year experience.
5.3.3 The team will consist of management and operational staff.
5.4 Conduction of Self-Inspection:
5.4.1 Self-inspection date will be communicated by team leader to the respective department one
week prior to execution.
5.4.2 Self-inspection of the operation should be carried out during normal working hours when
personnel are present.
5.4.3 The self-inspection team will visit the area to be inspected and inspect thoroughly, observe the
points needing attention, and identify any deviation from GMP/standard process.
5.4.4 Check lists are prepared as a reminder.
5.4.5 The self-inspection team will review the department practices versus the existing SOP’s
practices, records, worksheets, etc. against QMS regulatory requirements.
5.5 Recording and Reporting of Findings
The self-inspection report will be prepared by the self-inspection team, identifying findings.
5.5.1 The findings should contain the following information:
5.5.1.1 Title: Use SOP # or relevant document to describe the subject matter.
5.5.1.2 Description: A brief factual description of the deficiency, the system or the area
affected.
5.5.1.3 Supporting evidence: (If any) evidence might be in shape of copy of recorded sheet
i.e. calibration, sticker, certificate.
5.5.1.4 Team leader will issue the report to the department manager within two weeks from
self-inspection conducted date.

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 STANDARD OPERATING PROCEDURE
DEPARTEMNT QUALITY ASSURANCE
Title Self-Inspection
Doc. No. Revision No. Issue Date Effective Date Next Revision Date
QA-G-SOP-009 00
Replaces. N/A
Prepared By Reviewed By Approved By Authorized By
Name Kiran Tauqeer Ali Raza Sawar Khan Sarah Shaikh
Designation QA Executive AM Quality Assurance QA Manager GM Quality Operations
Signature
Date
CONFIDENTIAL- This document is the property of Rotex Pharma Pvt. Ltd. and should not be shared, reproduced or duplicated without QA consent.
5.5.1.5 The findings of the self-inspection should be noted down by the team and discussed
with Department Manager.
5.5.1.6 The finding report copy will be escalated to Quality Assurance Department.
5.5.1.7 Report reference shall be as SI/Depart.name/freq-year.
NOTE: Outstanding findings to be carried forward in next self-inspection.
5.6 Findings Classification
The self-inspection team will classify the findings according to severity into:
5.6.1 Critical:
Deficiencies which have a high probability of causing adverse consequences to the patient or
consumer may result in significant deviations in the safety, identity, strength, or the purity of
the product, or a combination of major deficiencies which indicates a critical system failure.
5.6.2 Major:
Deficiencies which could potentially cause adverse consequences to the patient or consumer if
left un-addressed, could be considered indicative of poor control, could be considered major
deviations by regulatory authorities, or a combination of minor deficiencies which indicate a
major systems failure, or a number of repetitive minor deficiencies.
5.6.3 Minor:
A deficiency which cannot be classified as critical or major.

Note: Critical findings will be escalated to quality assurance manager and immediately by the
self-inspection leader through department manager.
6 CAPA/COMPLIANCE AND RESPONSIBILITY
6.6.1 The Departmental Manager reviews the self-inspection findings and prepares CAPAs/action plan
that addresses all of the findings, assign responsibilities and target date within two weeks.
6.6.2 The copies of compliance reports should be submitted to QA Department before conduction of
second self-inspection. Original should be maintained with the concerned Departmental Head
7 FOLLOW-UP ACTION
There should be an effective follow-up programme. The management should evaluate both the self-
inspection report and the corrective actions as necessary.

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 STANDARD OPERATING PROCEDURE
DEPARTEMNT QUALITY ASSURANCE
Title Self-Inspection
Doc. No. Revision No. Issue Date Effective Date Next Revision Date
QA-G-SOP-009 00
Replaces. N/A
Prepared By Reviewed By Approved By Authorized By
Name Kiran Tauqeer Ali Raza Sawar Khan Sarah Shaikh
Designation QA Executive AM Quality Assurance QA Manager GM Quality Operations
Signature
Date
CONFIDENTIAL- This document is the property of Rotex Pharma Pvt. Ltd. and should not be shared, reproduced or duplicated without QA consent.
8 FLOW CHART

Create and maintain self-inspection schedule.

Prepare for self-inspection and develop self-

inspection team.

Conduct the self-inspection.

Record and report the findings.

Propose, review and agree the CAPA.

Department manager must

prepare CAPA and action plan.

QA manager agrees to the

CAPA.

Progress CAPA to closure.

Submission of Report.

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 STANDARD OPERATING PROCEDURE
DEPARTEMNT QUALITY ASSURANCE
Title Self-Inspection
Doc. No. Revision No. Issue Date Effective Date Next Revision Date
QA-G-SOP-009 00
Replaces. N/A
Prepared By Reviewed By Approved By Authorized By
Name Kiran Tauqeer Ali Raza Sawar Khan Sarah Shaikh
Designation QA Executive AM Quality Assurance QA Manager GM Quality Operations
Signature
Date
CONFIDENTIAL- This document is the property of Rotex Pharma Pvt. Ltd. and should not be shared, reproduced or duplicated without QA consent.
9 CHANGE HISTORY
Supersede CLAUS
DATE CHANGE MADE
SOP number E#
Dec-2023 N/A N/A New SOP and first version.

10 RELATED DOCUMENTS
Self-inspection Schedule QA-F-0032
Self-Inspection Report QA-F-0033
Definitions of findings QA-F-0034
Self-inspection reminders QA-F-0035
11 REFERENCE
WHO Technical Report Series 908.
12 DISTRIBUTION LIST
1. Quality Control
2. Production Pharma
3. HR & Admin
4. Warehouse Pharma
5. R&D
6. Engineering

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