Internal Audit
Contents:
1. Definition of Internal Audit
2. The objectives of internal audit
3. Types of Internal Audit
4. Area for self inspection
5. Frequency of Internal Audit
6. Selection and qualification of the inspectors
7. Internal Audit Process
Prepared by: Dr. Mohamed Abdel Naby
Definition of Internal Audit
• An Internal Audit is a systematic, independent, and documented
process carried out to evaluate the manufacturer’s compliance with
GMP in all aspects of production and quality control
• To evaluate whether a pharmaceutical company’s operations,
processes, and quality systems comply with:
➢Regulatory requirements (e.g., FDA, EMA, SFDA).
➢Internal company policies.
➢Standard Operating Procedures (SOPs).
Prepared by: Dr. Mohamed Abdel Naby
The objectives of internal audit
• Regulatory compliance: Ensures the company follows all laws and
regulations, avoiding penalties or warning letters.
• Quality improvement: Identifies weaknesses or deviations before they
escalate into serious issues (e.g., product recalls, batch rejections).
• Continuous improvement: Provides opportunities for corrective and
preventive actions to enhance operations.
• Inspection readiness: Prepares the company for external regulatory
inspections and certifications
Prepared by: Dr. Mohamed Abdel Naby
Types of Internal Audit
1. Scheduled (planned) internal audit: according to the predetermined
schedule based on the risk assessment.
2. Unscheduled internal audit (event-induced): performed with or
without informing the auditee like in the following cases:
• Receipt of critical observation during regulatory audit.
• Before external audits by regulatory authorities.
• Incase of critical deviations or complaints
• Recall related to GMP issue.
• In case of department evaluation was un accepted or accepted with
restrictions.
Prepared by: Dr. Mohamed Abdel Naby
Area for self inspection
1. Technical areas: all departments that can affect the product quality and/or related processes
should be checked using self-inspections, Including:
a) personnel
b) Premises including changing rooms/personnel locks
c) Servicing and maintenance of buildings and facilities
d) Procurement and storage of starting materials, packaging materials, intermediates and finished
products
e) Production processes and in-process controls
f) Validation and qualification programmes
g) Quality Control
h) Documentation
i) Cleaning, disinfection and hygiene
2. Non technical areas: departments that don’t affect the product quality and/or related processes
Prepared by: Dr. Mohamed Abdel Naby
Frequency of Internal Audit
• The frequency at which self-inspections are conducted may depend
on company requirements but should preferably be at least once a year.
• The responsible department prepare an annual GMP internal audit plan
start every year take in consideration department risk evaluation
Prepared by: Dr. Mohamed Abdel Naby
Frequency of Internal Audit
• Risk assessment criteria:
A. Process Complexity
B. Previous audit observation
C. Number of complaints
D. Number of recalls
E. Number of deviations
F. Number of change controls
G. Over due CAPA
Prepared by: Dr. Mohamed Abdel Naby
Selection and qualification of the inspectors
• Self-inspection team
• Management should appoint a self-inspection team consisting of
experts in their respective fields and familiar with GMP. The members
of the team may be appointed from inside or outside the company.
The WHO GMP guideline refer to self inspection teams consisting of 2-
4 persons are recommended.
The team should shall consist of lead auditor plus one to two auditors
inspectors
Prepared by: Dr. Mohamed Abdel Naby
Selection and qualification of the
inspectors
• Criteria for selection of Lead Auditor including technical & personal
experiences:
A. Auditing experience
B. Knowledge of audited department, processes and facilities
C. Familiar with cGMP requirements
D. Knowledge of SOPs.
E. Familiar with auditing preparation ,execution preparation, execution and
reporting
F. Leadership skills
G. Time management skills
H. Problem solving
Prepared by: Dr. Mohamed Abdel Naby
Selection and qualification of the
inspectors
• Technical and personal qualification requirements of inspectors:
• Regular participation in the further training.
• Knowledge of the method for inspection and assessment.
• Analytical capabilities for surveying complex process.
• Has persistence ability to concentrate even in stressful situations
• Works thoroughly and properly.
• Works purposefully and is not easily distracted.
Prepared by: Dr. Mohamed Abdel Naby
Internal Audit Process
• Self-inspection process consist of:
I. Internal audit notification
II. Performing Preparing Audit
III. Conducting Audit
IV. Reporting the audit Reporting
V. Audit follow-up
Prepared by: Dr. Mohamed Abdel Naby
Internal Audit Process
1. Internal audit notification:
Internal audit responsible make notification sent to auditee department
either by e-mail or hard copy.
• The notification should be Time-bounded
• The notification include:
A. the date and time of audit
B. Agenda of the audit
Prepared by: Dr. Mohamed Abdel Naby
Internal Audit Process
2- Performing Preparing Audit:
• Audit team shall Review all documents related to audit process.
• Audit team shall Review previous internal and external audit external
audit findings related to the auditee department.
• collect and evaluate potential deviations, complaints, anomalies and, if
applicable, measures specified during official inspections.
• contains a checklist that can be used as a basis for a self-inspection.
• The better the preparation, the more effective and efficient the actual
self-inspection.
Prepared by: Dr. Mohamed Abdel Naby
Internal Audit Process
3- Conducting Audit:
A. An opening meeting:
• shall be held by Lead Auditor conduct opening meeting to explain purpose, period, scope, criteria and sequence of audit .
• The inspectors and the inspected should realise that the main objective of self-inspection is improvement and that all
potential problems, weaknesses and uncertainties should be dealt with in an open manner.
B. Implementation:
• Audit should be preferably carried out in accordance with sequence of the audited operation if applicable (Horizontally) or
may be carried out through traceability of history of manufactured batch (Vertically).
• Information is collected by way of observation and discussion.
• Significant changes in facilities, equipment, products or key personnel since last audit should be noted as this change may
be a reason for non conformance.
• Each auditor records findings.
C. Close meeting:
• As a wrap up meeting after finishing the audit the auditors shall explain the explain findings (observations and NCRs) to
auditee for information
Prepared by: Dr. Mohamed Abdel Naby
Internal Audit Process
4- Reporting the audit Reporting:
• The reporting should be Time-bounded.
• the observations can be summarized and, if required, commented on by the inspected.
This is to prevent misunderstandings
• Positive aspects and observations as well as improvements in relation to previous
inspections should also be highlighted.
• Audit evidence shall be evaluated against the audit criteria in order to determine audit
findings.
• The audit findings are classified to Critical, Major or minor and recorded in the report.
• The Internal audit department should propose the corrective and preventive actions that
should be taken along with the audited department within the specified time frame
• The auditee should shall begins the investigation and compliance immediately in case of
critical findings or any issue necessitate immediate correction.
Prepared by: Dr. Mohamed Abdel Naby
Internal Audit Process
5- Audit follow-up:
• The internal audit team make follow up for the CAPA completion
within the agreed time frame.
• After the agreed time has elapsed, GMP compliance team shall go to
the area concerned and evaluate the degree of implementation of each
CAPA required.
Prepared by: Dr. Mohamed Abdel Naby
