This PPT gives the idea about importance of audit. Every QA personnel should aware about the fact behind every aspects of audit. This PPT is useful for all auditor in pharmaceutical domain.

1. Prepared By:
Piyush V. Wagh
Senior Executive
Quality Assurance Department
Date: 30th Aug 18
Ref: image downloaded from presenter media
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2. Critical Aspects During Audit (BABE)
What is Quality?
Quality can be say as:
 The standard of something as measured against
other things of a similar kind;
 the degree of excellence of service.
A more simple definition is to
Adherence to “Standard”
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3. Critical Aspects During Audit (BABE)
Protocol
SOP
Guideline
Image downloaded from: 123RF.com
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4. Critical Aspects During Audit (BABE)
Essential Elements of Quality Management
 The quality policy must be clearly stated and drive should come
from management – “Quality Policy”
 Required standards, guidelines understood and properly followed
– “Training”
 System must be capable of preventing errors, emphasis on
prevention – “Preventive Action”
 Independent assessment of compliance (measure the trend) –
“Trend of findings”
 Flexible system (many regulations to follow)
 State individual responsibilities clearly in quality management-
“Auditor- role and responsibility”
Adapted from the Qa in ba be (Mr. Prabhat Kumar) – link: https://www.slideshare.net/prabhugoa/qa-in-ba-be
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5. Critical Aspects During Audit (BABE)
System must be capable of preventing errors, importance on prevention
Don’t Be a Traffic Police 5
Ref: image downloaded from presenter media

6. Critical Aspects During Audit (BABE)
Basic Variable
1. Man – “Employee”
2. Material
3. Method – “Operating Procedure”
4. Equipment
5. Environment
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7. Critical Aspects During Audit (BABE)
Clinical QA
(GCP)
ICH (E6)
FDA, EMEA
Countries Regulation
(DCGI)
Bioanalytical QA
(GLP)
FDA, EMEA
OECD
Countries Regulation
Other’s
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8. Critical Aspects During Audit (BABE)
Definitions Good Clinical Practice (GCP):
A standard for the design, conduct, performance ,
monitoring , auditing , recording, analyses, and reporting
of clinical trials that provides assurance that the data and
reported results are credible and accurate, and that the
rights, integrity, and confidentiality of trial subjects are
protected. [1.24, ICH Topic E6, GCP]
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9. Analyses
Perform
Auditing
Monitoring
Recording
Conduct
Design
Reporting
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10. Critical Aspects During Audit (BABE)
What is Quality Assurance (QA)
All those planned and systematic actions that
are established to ensure that the trial is
performed and the data are generated,
documented (recorded), and reported in
compliance with Good Clinical Practice (GCP)
and the applicable regulatory requirement(s).
(1.46- ICH-GCP E6(R2))
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11. Critical Aspects During Audit (BABE)
Trial Performed
Trial Data generated
Trial Data Recorded
Trial Data Reported
E
n
S
U
R
E
Compliance
with ?
Compliance
with ?
Compliance
with ?
E
n
S
U
R
E
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12. Critical Aspects During Audit (BABE)
What is Audit?
A systematic and independent examination of trial
related activities and documents to determine
whether the evaluated trial related activities were
conducted, and the data were recorded, analyzed
and accurately reported according to the
protocol, sponsor's standard operating
procedures (SOPs), Good Clinical Practice (GCP),
and the applicable regulatory requirement(s).
(1.6 ICH-GCPE6(R2))
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13. Conducted
Data were recorded
Data were analyzed
Trial related data
were accurately
reported
A
U
D
I
T
P
R
O
T
O
C
O
L
S
O
P
G
C
P
Systematic,
independent
P
R
O
T
O
C
O
L
S
O
P
G
C
P
G
C
P
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14. Critical Aspects During Audit (BABE)
Case 01 – (For CR QA)- Protocol Compliance
Performed?
Data generated ?
Data recorded
accurately ?
Data reported
accurately ?
In-process audit- Actually screening was
performed?
Logbooks, Forms, computerized data, ECG, X-
ray films, (Source Data)
Screening Records, CRF
Clinical Study Report
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15. Critical Aspects During Audit (BABE)
Case 01 – (For CR QA)- Protocol Compliance
Performed?
Data generated ?
Data recorded
accurately ?
Data reported
accurately?
Actually performed ?
Logbooks, Forms, CRF (Source Data)
CRF –section “Check-in details”, Meal
Records?
Clinical Study Report
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16. Critical Aspects During Audit (BABE)
Case 01 – (For CR QA)- Protocol Compliance
Performed?
Data generated ?
Data recorded
accurately ?
Data reported
accurately?
Actually performed ?
Logbooks, Forms, CRF (Source Data)
BCR?
Clinical Study Report
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17. Critical Aspects During Audit (BABE)
Case 01 – (For CR QA)- SOP Compliance
Performed?
Data generated ?
Data recorded
accurately ?
Data reported
accurately?
Actually performed ?
CRF (Source Data)
CRF
Clinical Study Report
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18. Critical Aspects During Audit (BABE)
Case 01 – (For CR QA)- SOP Compliance
Performed?
Data generated ?
Data recorded
accurately ?
Data reported
accurately?
Actually performed by PI and CI only?
BCR (Source Data)
CRF-BCR- verified by sign?
Clinical Study Report
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19. Critical Aspects During Audit (BABE)
Case 01 – (For BR QA)- SOP Compliance
Performed?
Data generated ?
Data recorded
accurately ?
Data reported
accurately?
Actually performed?
Forms, Logbook (Source Data)
Recorded by- Forms and
verified by ?
Analytical Study Report
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20. Critical Aspects During Audit (BABE)
Case 01 – (For BR QA)-SOP Compliance
Performed?
Data generated ?
Data recorded
accurately ?
Data reported
accurately?
Actually performed?
Form, Logbook –Computer print-out
Forms, logbook ?
Analytical Study Report
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21. Critical Aspects During Audit (BABE)
Case 01 – (For CR and BR QA)- GCP Compliance
Data generated ?
Data recorded
accurately ?
Data reported
accurately?
Approval Letter, In-house SOP forms
Forms, Logbook (if any)
Clinical Study Report
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22. Critical Aspects During Audit (BABE)
Who is Auditor?
BABE study Generation of Data
Compliance as per GCP
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Ref: image downloaded from presenter media and different regulatory sites, goggle images
Contract Research
Organization

23. Critical Aspects During Audit (BABE)
Role of Auditor
 Confirm GxP (GCP,GLP) Compliance
 Act as Catalyst for Quality Improvement
 Provide Advice on GxP (GCP,GLP) matter
 Provide training to research staff
 To establish a quality and compliance based culture.
 Maintained their own audit schedule
 Plan audit is necessary
 Aware of planned study
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24. Critical Aspects During Audit (BABE)
Planned action
Planned activity?
•Study Plan ?
•System Audit Plan?
•Vendor Audit Plan ?
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25. Critical Aspects During Audit (BABE)
Systematic action
Systematic action?
• Check-list?
• Execution of Audit?
• Systematic Follow-up findings closure?
• Every Documentation that QA does?
• Routes of Communication of findings ?
• Systematic Closure of deviation?
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26. Critical Aspects During Audit (BABE)
Preparation of Audit
• Review of protocol, guideline, SOP, Past audit report
• Take sufficient time for audit (must be qualitative)
• Document every observation and findings.
• Every findings discussed with respective staff
• You should know about corrective action.
• Inform immediately about critical findings to HOD’s
Auditor should be prepared for audit by:
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27. Critical Aspects During Audit (BABE)
Target the event
Target the Non-
compliance
Target the
Procedure
Don’t target
people
Target during
audit?
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Ref: image downloaded from presenter media and different regulatory sites, goggle images

28. Critical Aspects During Audit (BABE)
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29. Critical Aspects During Audit (BABE)
Quality of Best Auditor
• Training expertise and experience
• Familiar with every SOP.
• In depth knowledge of applicable Guideline
• Eyes for details
• Understand the basic concept of underlying the
activity being monitored.
• To know what to do and why to do?
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30. Critical Aspects During Audit (BABE)
What does QA do?
• Readiness of Site for external audit
• Internal processes are effectively implemented
• Data generated is valid and verified
• Check the whether study personnel are compliant with
their Role and responsibility?
• Duplication of work!
• Don’t forget “RIGHT”, “Safety” and “Well-being” of
subject
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31. Critical Aspects During Audit (BABE)
You are the Part of QMS
• Anticipate the error- Audit all ways a process could fail
and make improvement to ensure it doesn't.
• Procedure- Developed clear system and procedure
• Training – Ensure every personnel are trained as per
their role.
• Validate- All operation must be validate
• Avoid Short cut: Follow the SOP’s.
• Challenge what you do? – Regularly check that
system meet applicable standard.
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32. Critical Aspects During Audit (BABE)
Become the Best auditor
To read SOP, Guideline
To be professional
To be part of QMS
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Ref: image downloaded from presenter media

33. Critical Aspects During Audit (BABE)
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Ref: image downloaded from presenter media