Standard Operating Procedure for Internal Audit

1.0 Objective
To lay down a procedure for periodic internal audit and self-inspection to ensure
current Good Manufacturing practices compliance.
2.0 Scope
This Standard Operating Procedure is applicable to all departments of the
pharmaceutical formulation plant.
3.0 Responsibility
3.1 Audit Team: Auditing the facility and to prepare audit report comprising or
recommendations and corrective action necessary for respective departments.
3.2 Auditee Head: Head of the audited department, to ensure access is provided to
internal audit team to the department and relevant documents required by internal
audit team. He or she shall also ensure that corrective actions are taken within a
specified time frame as mentioned in the internal audit report.
3.3 Head-QA: Audit team constitution, audit schedule approval and distribution of
Audit Report and Head-QA shall also ensure the compliance to the procedure.
4.0 Accountability
4.1 Department Heads & QA Head shall be accountable for the implementation of
this SOP.
5.0 Abbreviations and Definitions
SOP:  Standard Operating Procedure; a document where step by step instructions
are cited to serve as support for methods or manners of fulfilling a function or
functions reliably and consistently.
Internal Audit: An onsite verification of activity used to determine effective
implementation of documented quality systems.
Self-Inspection: Verification of departmental activity used to determine effective
implementation of documented quality systems.
Audit: Word represents both Internal Audit and Self Inspection.
Auditor: A person who has the technical qualification or is trained or the experience
to perform audits.
Auditee: A department to be audited.
QA : Quality Assurance
GMP : Good Manufacturing Practices
cGMP : Current Good Manufacturing Practices
Ltd.  : Limited

6.0 Procedure
6.1 Audit shall be carried out at two levels. Self-inspection and Internal Audit.
6.1.1 Self-Inspection is done at departmental level i.e. representative of
department shall perform inspection of all the documents and activities done by the
department. Self-Inspection shall be conducted once in every two months. The Self
Inspection shall have ±7 day’s acceptable tolerance and inspection shall be done
within this period. These representatives shall be nominated as auditors by the
Department Head and shall have direct reporting to department head. An audit
report shall be prepared and corrective and preventive action shall be determined,
filed and implemented. The representatives shall perform the audit of previous
month document and activities.
6.1.2 Internal Audit shall be carried out by QA & / or by an audit team constituted
by head QA in all operational departments. While selecting a team member for
audit team, the head QA shall ensure that the member is not from the same
department for which audit is to be carried out.
6.2 Internal Audit shall be carried out as per the schedule prepared by QA
department. The month and department to be audited shall be mentioned in the
internal audit planner, which shall be prepared annually. This Internal audit planner
shall be circulated to concerned department by Head-QA, preferably in the month of
December of every fiscal year. The actual dates of audit shall be proposed by QA
before executing the audit.
6.2.1 The internal audit planner shall be distributed in triplicates, one copy each for
planned date from QA and the agreed date from the user department and one for
QA department for execution reference.
6.2.2 The Internal audit shall have ±15 days’ acceptable tolerance and Audit shall
be done within this period.
6.2.3 If internal audit of any particular department / activity is required towards the
investigation/ addressing of the product complaint or product recall the same shall
be performed any time.
6.3 During the audit, auditors shall use the checklists for each department, but the
scope of audit may not be restricted to the checklist only. In checklist under the
‘Remarks’ column, the auditor shall mention whether the observation is adequate or
inadequate.
6.4 The audit team shall evaluate systems, processes, and functions of the
department to ascertain current level of the cGMP. The audit team shall check for
the compliance for the various procedures, raw data and record the findings in
“Internal Audit/Self Inspection Report”.
6.5 Observation made during the audit shall be discussed with the concerned in-
charge of the concerned department and / or the head of the department.
Depending on the nature of the findings and the risk associated with any non-
compliance, the following classifications shall be used.