Doc #: M/SOP/RA/006

STANDARD OPERATING PROCEDURE Revision # 01

Effective Date 06-07-2023

Department Regulatory Affairs Next Review Date 06-07-2025
Title SOP For Internal Inspection/Audit as per Regulatory Guidelines
Prepared By Reviewed By Approved By
Assistant Manager Regulatory
Designation Regulatory Affairs officer Manager Regulatory Affairs
Affairs
Signature
Date
1.PURPOSE:
1.1 Auditing manufacturing processes in the herbal industry is a standard part of most quality system
plans today. An internal audit helps assess the internal control of a system and measure the
effectiveness of the quality system
2. SCOPE:
2.1 This standard operating procedure gives the procedure for self-inspection.
3. RESPONSIBILITY:
3.1 Department In-charge/Section In-charge:
3.1.1 To assist auditors during audit.
3.1.2 To fulfill the noncompliance noted during audit.
3.1.3 Reviewing of Inspection Report for effective follow up program.
3.1.4 Monitoring corrective actions and subsequent implementations.
3.2 Authorized Designee of regulatory affairs Manager :
3.2.1 To make internal audit schedule & Intimation to the department as per schedule.
3.3 Head QA :
3.3.1 Selection of inspection Team (Other than concern Dept.)
3.3.2 Approval of Internal audit schedule.
3.3.3 Reviewing of Inspection Report
3.3.4 Ensuring action plan and its compliance
3.4 Self - Inspection Team:
3.4.1 Lead Auditor:
3.4.1.1 Lead Auditor to lead the self-Inspection Team, execute the Inspection on the plan date and prepare of Self
Inspection report.
3.4.2 Team Member:
3.4.2.1 Team member to support the lead Auditors for execution of inspection and report preparation
3.4.3 Auditee:
3.4.3.1 To assist with the auditors at the time of inspection and comply with the Non-conformances reported by
the Auditors.
3.4.4 Head of Regulatory Department:
3.4.4.1 Is responsible for planning, team selection, and leading of inspection team and closing of -inspection
report.
4. MATERIAL & EQUIPMENT:
4.1 Not Applicable
5 PROCEDURE:
5.1 Selection of Self inspection team:
5.1.1 Head Regulatory Department will select a cross-functional self-inspection team from various departments
such as Quality Ass, Quality Control, Production and Store before the start of every calendar year.
5.1.2 Select the auditors in the self-inspection team based on their qualification, experience, expertise,
technical skills and power of logical analysis.
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 Doc #: M/SOP/RA/006

STANDARD OPERATING PROCEDURE Revision # 01

Effective Date 06-07-2023

Department Regulatory Affairs Next Review Date 06-07-2025
Title SOP For Internal Inspection/Audit as per Regulatory Guidelines
Prepared By Reviewed By Approved By
Assistant Manager Regulatory
Designation Regulatory Affairs officer Manager Regulatory Affairs
Affairs
Signature
Date
5.1.3
Ensure that the Inspection Team is comprise of two members (at least but not limited to) and Head –QA
or his authorized designee is the lead auditor.
5.1.4 Ensure that the self-inspection team is comprised of lead auditors and team members. Lead auditors are
specific based on their expertise in the different areas as identified by regulatory affair head.
5.1.5 Ensure that Lead auditors/ Team members in the specific self-inspection team are not being of an Auditee
department, where the self-inspection is planned.
5.2 Preparation of Self inspection schedule/ Planner:
5.2.1 Authorized Designee of regulatory affair: Prepare the yearly self-inspection schedule before the start of
every calendar year, which includes all the functional departments such as Quality Assurance, Quality
Control, Production, Store, .Forward the yearly self-inspection schedule to Head regulatory affair for
review and approval.
5.2.2 Head regulatory affair: Review and approve the inspection schedule.
5.2.3 Forward the approved self-inspection schedule to all the head of departments.
5.3 Planning of Self inspection:
5.3.1 Authorized designee of regulatory affair shall forward the filled Inspection Planning Form with all details
e.g. audit date, auditors etc. to, One week prior to plan date of Self Inspection to HOD of Auditee
department with marking of one copy to team members identified for self-inspection, identified for Self
Inspection.
5.3.2 Depending upon the work planning, head of concerned department may accept the planned self-
inspection date or can propose another date for self-inspection, however the proposed date shall be within
the same month and the same shall be verified by Head- Quality Assurance.
5.4 Execution of Self Inspection:
5.4.1 Audit may be conducted by using guidance checklist during the audit and shall perform based on the
expertise of the auditor and current guidelines.
5.4.2 Conduct the inspection & record all observations. In case inspection is not completed in one day,
continue on next day or any other agreed day.
5.4.3 During Self Inspection, relevant supporting documents shall be verified for compliance.
5.4.4 After the completion of self-inspection, all the team members shall discuss and finalize the deficiencies
observed during the audit.
5.4.5 Formally detail the Non – conformance observed during the Self Inspection and discuss with the Auditee
during Self Inspection closing meeting.
5.5 Preparation of Self Inspection Report and Compliance report:
5.5.1 Self-Inspection Report shall be prepared within two days from the date of inspection and circulated to the
concerned department head and record the same in the Self Inspection file.
5.5.2 Respective department heads are responsible for preparing the Compliance Report for the deficiencies
reported within a period of 7 days from the receipt of self-inspection report and submit to Quality
Assurance. The date of receipt of compliance report shall be recorded in Self Inspection file.
5.5.3 Head –Regulatory or his authorized designee shall review and assess the compliance Report.
5.5.4 If compliance verification by regulatory affair representative is found satisfactory and the Auditee
department closes all the non-conformances, authorized designee shall mention the closure date in
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 Doc #: M/SOP/RA/006

STANDARD OPERATING PROCEDURE Revision # 01

Effective Date 06-07-2023

Department Regulatory Affairs Next Review Date 06-07-2025
Title SOP For Internal Inspection/Audit as per Regulatory Guidelines
Prepared By Reviewed By Approved By
Assistant Manager Regulatory
Designation Regulatory Affairs officer Manager Regulatory Affairs
Affairs
Signature
Date
compliance report as well as in self-inspection file.
5.5.5
Head – Regulatory shall finally prepare a Conclusion Report of Self Inspection department wise.
5.5.6
The conclusion report shall include a brief note on deficiency, the proposed corrective and preventive
action, evaluation comments and recommendations.
5.5.7 Head Regulatory or designee if needed to monitor the proposed corrective action and its
implementation shall seek a follow up inspection.
5.5.8 All self-inspection documentations are archived in Regulatory Department.
5.5.9 Keep all the self-inspection observation reports confidential as an internal system improvement, which is
strictly prohibited for external reviews.
5.6 Frequency of Self Inspection:
5.6.1 The frequency of self-inspection is scheduled as twice a year.
5.6.2 In case of any critical market compliant, product recall related to quality issue or critical GMP
nonconformance e.g. Product mix ups, batch failure, self-inspection can be initiated in the respective
areas/systems before the schedule.
5.6.3 In case of inspection or directions from regulatory agency.
5.6.4 Unscheduled inspections may be carried out at the direction of Head regulatory affair.
6. REPORTING:
6.1 Inspection check list(M/QA/QF/0709)
6.2 Self-inspection logbook / File( M/QA/QF/0707)
6.3 Self-Inspection Logbook (M/QA/QF/0703)
6.4 Self Inspection Compliance Report (M/QA/QF/0706)
6.5 Self-inspection summary report(M/QA/QF/0705)
7. REFERENCE DOCUMENTS:
7.1 In house
.

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 Doc #: M/SOP/RA/006

STANDARD OPERATING PROCEDURE Revision # 01

Effective Date 06-07-2023

Department Regulatory Affairs Next Review Date 06-07-2025
Title SOP For Internal Inspection/Audit as per Regulatory Guidelines
Prepared By Reviewed By Approved By
Assistant Manager Regulatory
Designation Regulatory Affairs officer Manager Regulatory Affairs
Affairs
Signature
Date

Revision History

Revision # Nature Of Amendment

01 First revision on new format & with new Document Code System

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