CONTENT OF PRESENTATION
I. Introduction
Objectives
Description of GMP Audit
Scope of GMP Audit
Benefits of GMP Audit
The key principle of GMP Audit
The role of GMP Auditor
2. Managing the GMP Audit program
Process Flow for Managing of an audit program
Authority of audit program
Establishing the audit program
Audit program implementation
Monitoring and Reviewing the audit program
3. Audit Activities
Overview of Audit Activities
Initiating the audit
Conducting Document Review
Preparing for On site audit activities
Conducting on-site audit activities
Preparing, approving & distributing the audit report
Completing & Conducting Follow up
4. Audit Format
5. Conclusion
OBJECTIVES
To define the activities and requirements of GMP Audit
To identify the roles and benefits of GMP Audit in a
pharmaceutical industry
To learn how to plan, perform and monitor GMP Audit
DEFINITION
“GMP Audit" is an independent examination of a
quality system
It measures the effectiveness of an organization's
Quality Management System.
It is a documented and systematic tool
It should be done periodically by independent and
qualified people
“Audit" itself is a checking system, NOT a
quality assessment
As a communication tool of management policies.
All personnel have to understand and do their jobs
well
ROLES OF AUDIT
Its used a powerful tool to measure the
effectiveness of Quality Management System
Evaluates manufacturer’s compliance with GMP
in all aspects related QA, production and
quality control
Detects any shortcomings in the implementation
of GMP
Recommend the necessary corrective and
preventive actions
BENEFITS OF GMP AUDIT
Tells you the hygiene standard of area
Identify the root of a problem and plan for corrective
and preventive actions with timeline
Achieve better allocation of resources
Learn what an auditors look for
Continuous improvement
KEY PRINCIPLES OF GMP AUDIT
Approaches towards GMP Audit:
• Independent
• Evidence-based approach
All activities related to Audit should:
• be reviewed by an independent party
• be a self-appraisal system
• have a sampling plan and tracking system
• be open, constructive and effective
Strategies in conducting audit:
• Ask with the basic audit questions about the quality
system in place
• Start with what, why, how, who, where, when
PRINCIPLE OF AN AUDITOR
Ethical
Professional
Fair
Auditing Techniques
Do Don’t
Be friendly Judge
Focus on listening Embellish
Remove distractions Inattentive
Empathize
Speak unclearly
Patience
Hold your temper
Talk excessively
Question
Phrase yes/no
Be humble
questions
LISTEN
Display an attitude
Argue
Criticize
Answer your question
GUIDANCE WHEN CONDUCTING AN AUDIT
• Auditing should be seen as a positive process not a fault finding
• Audits need to be documented
• Prior to the audit date, an auditor needs to review the quality
system documentation, corrective and preventive actions, and past
audit findings.
• During an audit, an auditor need to see evidences that the
processes are being done in accordance to procedures and policies
GUIDANCE FOR AUDITEE
When being audited:
• Volunteer information
• Report deficiencies and difficulties if you know of any
• Be honest, open and cooperative
• Ensure that underlying causes are identified
• Ask the auditor if you’re not sure
FLOW CHART OF AUDIT
Authority for theaudit
programme
Establishing
the GMP audit program
obectives
responsibilitties Plan
resources
procedure and guidance
Implementing GMP audit program competence and
scheduling audits evaluation of
evaluating auditors auditors
Do
selecting audit team
Improving theaudit directing audit activities
Act Audit activities
programme maintaining records
Monitoring & reviewing
the GMP audit program
monitoring & reviewing
Check
identifying needs for corrective
identifying needs for prevention actions
identifying opportunities for improvement
RESOURCES FOR AUDIT
Considerations should be given to the following:
Resources
Audit techniques
Processes to achieve and maintain the competency
of auditors and to improve their performance
Competency and availability of auditor
Available time for auditing
OVERVIEW OF AUDIT ACTIVITES
Planning and scheduling audit
Conducting document review
Preparing for on-site activities
Conducting audit
Prepare audit report
Conducting follow-up
AUDIT ACTIVITIES
Forming an audit team and assign roles and
responsibility and agreed on the scope
Conducting document review
Review documents (SOPs, audit findings,
corrective action/preventive action, etc.),
check the integrity of the quality system
and various controls are effective
• Preparing for the on-site audit activities
Preparing audit plan
Assigning work to the auditors
Preparing work documents
(eg. audit checklists, sampling plans, forms
for recording information; questionnaires)
AUDIT DOCUMENTATION
• Audit plan
should be sent to Auditee prior to audit
activity
findings from the last audit should be also
mentioned
• Audit note should include
an audit questionnaire
all records and comments during the audit
• Audit report is an
official document to report the audit findings
EXAMPLE OF AN AUDIT CHECKLIST
Audit format for an audit checklist
Sr. Applicable Type Rating
Section – Personal Hygiene Remarks
No. Yes No PRP FSR A B C D
Almarai Uniform Protocol must be followed
1
by each employee
Smoking / Eating is not allowed inside the
2
manufacturing areas.
All employees must undergone thro
3
Baladiah Medical test
All cuts & grazes on exposed skin shall be
4
covered
Is regular fogging conducted? Are records
5
available for review?
Offices / Workplace shall be kept clean &
6
tidy
Definitions
Abbre # Categories Definitions Score
A Satisfactory Meets the requirement throughout the department 5
Minor Few incidence where department was not able to fulfill the
B 3
Deviation requirements (Based on situation & incidence criticality)
More no of incidences where the department was not able to
fulfill the requirements (Based on situation & incidence
Major
C criticality) 0
Deviation
Corrective Actions not taken place for last audit
A single incidence causing Risk to product e.g. Broken Glass
on floor, Foreign body issue
D Critical -3
Corrective Actions not taken place for consecutive last two
audits
EXAMPLE OF AN AUDIT CHECKLIST
CHECKING LIST FOR GMP ASSESSMENT
Date : Location : Warehouse
Auditor : Auditee :
DESCRIPTION GMP.REF. PARAMETER AUDIT FINDING
Personnel 1.2.1 - Organization structure
5.1.2 - Personnel hygiene
2.1.5 - Training record
Storage area 10.1.1 - Design and layout of defined area
3.1 - Flow of personnel and goods
3.6 - Structure of the storage area, based
3.9 & 3.10 on GMP
3.12.2 - HVAC system
- Record of monitoring parameter
Sanitation 3.1 - Pest record program
- The map of bait
5.3 - The cleanliness of weighing
apparatus
Documentation 4.3 - Record of maintenance and
calibration of weighing apparatus
10.2.2.3 - The effectiveness of label system
10.2.2.1 - Inventory stock control
AUDITING ACTIVITIES (1)
Conducting on-site audit activities
Conduct opening meeting
Good communication during the audit
Roles of escort and observer
Steps in conducting on site audit:
Interviews with different personnel
Carry out both horizontal and vertical audits.
Focus on safety and quality of product.
Use “Trace-back” method
AUDITING ACTIVITIES (2)
Generating audit findings
Either conformity or non-conformity
Sort out isolated or systemic deficiencies
Isolated deficiency:
Tends to happen randomly; no meaningful
pattern; rarely happens
Systemic deficiency:
Could be connected to a particular process,
product, material, person or organisation; shows
pattern; happens more than once
AUDIT MONITORING
The audit finding can be classified into 2 groups:
• Compliance :
• Satisfactory /Adequate
• Outstanding
Non-compliance :
• Critical deficiency
• Major deficiency
• Minor deficiency
AUDIT REPORT
Objectives
Audit scope
Identification of trained auditor
Date and place where the on-site
audit activities were conducted
Audit criteria and findings
Conclusions
AUDIT REPORT
Only Standard formats can be used for Audit Report
Usually include name and location of auditee, date of audit,
audit plan, audit observations, classification of non-
compliances, recommendations or expectations
Should write against a standard
Focus on deficient conditions and not people
Include any positive observations
Keep the audit report simple and clear
AUDIT REPORT: AN EXAMPLE
Section – Personal Applicable Type Rating
Sr. No. Remarks
Hygiene Yes No PRP FSR A B C D
Offices / Workplace shall be
1 √ √ √ Audit in Blending Room
kept clean & tidy
Do floor drains appear clean,
Audit in Fresh Filling (Drain
2 free from odors and well √ √ √ √
is near to recovery area
maintained?
Smoking / Eating is not
3 allowed inside the √ √ √ √ Audit in any production area
manufacturing areas.
Almarai Uniform Protocol
4 must be followed by each √ √ √ Audit in Down line
employee
All employees must
5 undergone thro Baladiah √ Audit in Outbound
Medical test
Is regular fogging
Audit in RCC Fermentation
6 conducted? Are records √ √ √ √
room
available for review?
Drains shall be fitted with
7 √ √ √ √ Audit in CHP Filling
screens & traps to pest entry
CLOSURE
Follow-up and closing of loop:
• Receive a satisfactory response from auditee and their
commitment to correct for any deficiency
• Ensures CAPA identify the root cause and they are
satisfactory, accomplished and documented
• Timeframe for CAPA is being followed
• Verify and track CAPA by scheduling a follow-up audit
and/or requesting for an updated SOP
CONCLUSIONS
Nobody likes to be
audited………..
It is a means to have
continuous
improvement
