Rashid Mureed gave a presentation on regulatory challenges with data integrity and data management. He discussed global standards and guidance from organizations like WHO, EMA, MHRA, and FDA. Common deficiencies seen include a lack of audit trails, improper user access controls, and inaccurate or fabricated test results. Mureed emphasized the importance of the ALCOA principles for data integrity and explained that most issues stem from technical failures and bad practices rather than willful misconduct. He provided recommendations for developing a data integrity action plan through risk assessment, defined procedures, training, and fostering a culture of quality.

1. Rashid Mureed
Head of Regulatory Affairs: OBS Group
(MSD Pakistan/OBS Pakistan/AGP & Aspin Pharma)
Regulatory Challenges Of Data
Integrity & Data Management
GCC Pharma Regulatory Summit

2. Presentation Highlights
Disclaimer: Material shared in presentation is in context of Health Authorities current guidance documents and
personal views based on inspection/ audit experiences.
Global
View
• Global Perspective and Standard Frame work
Experie
nce
• Learning experience during inspections- Industry Perspective
Challen
ges
• Main causes of regulatory challenges in data integrity
Future
• The Ultimate Era
ConfidentialData IntegrityMonday, April 10, 2017

3.  Introduction
 Global Perspective and Standard Frame work
 Change in Industry Focus
 Breaches of Data Integrity: Common Deficiencies
 ALCOA Principles
 Misconceptions About Data Integrity
 Data Integrity Action plan
 Concluding Remarks
 References
ConfidentialData IntegrityMonday, April 10, 2017
Agenda. . .

4. ConfidentialData IntegrityMonday, April 10, 2017
Introduction

5. Guidance on Good Data & Record
Management Practices
WHO
September
2015
GMP Data Integrity & Guidance for
Industry
MHRA March 2016
Data Integrity Compliance with
cGMP-Guidance for Industry
USFDA April 2016
EMA Data integrity Guidance EMA August 2016
Data Management & Integrity in
regulated GMP/GDP Environment
PIC/S August 2016
Guidance document on data integrity
in clinical trials
CFDA August 2016
ConfidentialData IntegrityMonday, April 10, 2017
Global Perspective and Standard Frame work
and so on….

6. • Punjab Institute Of Cardiology, Lahore
Pakistan
• GVK Biosciences: European Medicines
Agency Confirms Recommendation To
Suspend Medicines Over Flawed Studies
• USFDA Warning Letters
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Change in Industry Focus

7. Warning Letters From USFDA FY 2012-16
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8. Most Cited Deficiency Groups (Top 10)
RANKING GROUPS CRITICAL MAJOR OTHERS
1 QUALITY SYSTEM 27 293 555
2 COMPLAINTS & RECALL 10 25 94
3 DOCUMENTATION 9 138 372
4 QUALITY CONTROL 4 26 136
5 COMPUTERIZED SYSTEM 1 21 19
6 PRODUCTION 0 161 357
7 PREMISES & EQUIPMENT 0 107 311
8 VALIDATION 0 93 128
9 PERSONNEL 0 41 95
10 MATERIALS MANAGEMENT 0 19 134
ConfidentialData IntegrityMonday, April 10, 2017

9. Audit
Trail
• There is no record of data modification or deletion due to unavailability of audit trail
Audit
Trail
• The system owner access level is not described. A generic password in use
User
Account
• Copying formulation from another manufacture.
Trainin
g
• There was no formal record of assessment of competence for GMP training
Testing
• Reporting on COA that batches meet the test specification without actually performing
the test, or having any supporting data
Batch
records
• Manufacturing batch records IPC checks completed in advance of testing intervals
ConfidentialData IntegrityMonday, April 10, 2017
Breaches of Data Integrity: Common Deficiencies

10. Overag
es
• Use of overages but not recorded in BMR but confirmed from raw material register
Testing
• Blending API lots that had failed in testing with the once that had passed in order to
obtain desired specification test results.
Agree
ment
• There is no technical agreements with vendor.
Testing
• Multiple analyses with same sample without adequate justification
Insp
ection
• At the time of inspection, the company is not capable of fully explaining the
discrepancy noted
Stabilit
y
• Data recorded in stability summary reports were not reflective of the raw data
ConfidentialData IntegrityMonday, April 10, 2017
Breaches of Data Integrity: Common Deficiencies

11. Monday, April 10, 2017
• Clearly
indicates who
recorded the
data or
performed
the activity
• Signed/dated
• Who wrote it
/ when
Legible
• It must be
possible to
read or
interpret the
data after it is
recorded
• Permanent
• Properly
corrected if
necessary
Contemporaneous
• Data must be
recorded at
the time it
was
generated
• Close
proximity to
occurrence
Original
• Data must be
preserved in
its unaltered
state
• If not, why
not
• Certified
copies
•Date must
correctly
reflect the
action /
observation
made
•Data checked
where
necessary
Accurate
CLA O A
Attributable
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ALCOA Principles

12. ConfidentialData IntegrityMonday, April 10, 2017
Misconceptions About Data Integrity
Belief that DI problems are
limited to fraud or
falsification
Belief that you can trust
employees to follow
policies and procedures
Belief that DI issue are
not likely to happen at
your company
Belief that employee error,
when found, is the root
cause of DI issues and that
the solution is to retain
employee
Belief that recent
activities in data integrity
and enforcement in DI is
something new

13. SYSTEM FAILURE
WILLFUL FALSIFICATION-
BEHAVIORAL ASPECT
(20%)
TECHNICAL FAILURE-BAD
PRACTICE (80%)
ConfidentialData IntegrityMonday, April 10, 2017
Data Integrity Action plan

14. TECHNICAL FAILURE-BAD PRACTICE WILLFUL FALSIFICATION-BEHAVIORAL ASPECT
Not following the standard guidelines Culture of fear and blame
Formal risk assessment (shortage of
resources)
Poor attitude toward problems
Over commitment (Quantity over quality) Poor Education
Company defined standard procedures System that encourages good practice
Training Hierarchy
Life Cycle approach Pressure, Stress and Fatigue
ConfidentialData IntegrityMonday, April 10, 2017
Data Integrity Action plan

15. ConfidentialData IntegrityMonday, April 10, 2017
Concluding Remarks
Organization Image
Best proactive approach
Positive attitude toward Regulatory Guidelines
Ensuring that ALCOA principle are achieved
Getting the right culture of quality
Leadership and management understanding

16. Take Away Message
Monday, April 10, 2017 Data Integrity Confidential
C.S. Lewis
Integrity is doing the right thing even
when no one is watching

17.  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-
data-management-practices_QAS15-624_16092015.pdf
 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_00
0027.jsp&mid=WC0b01ac05800296ca#section16.
 http://academy.gmp-
compliance.org/guidemgr/files/MHRA_GxP_data_integrity_consultation.pdf.
 http://www.e-comlaw.com/ehealth-law-and-
policy/article_template.asp?Contents=Yes&from=ehlp&ID=344.
 https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf
 https://www.tga.gov.au/sites/default/files/presentation-data-integrity-international-regulatory-
perspective-160811.pdf
 https://www.picscheme.org/
 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/GVK_Biosci
ences/human_referral_000382.jsp&mid=WC0b01ac05805c516f
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References

18. THANKS!
QUESTIONS
Rashid Mureed
Pharm-D/MBA/LLB
rashid.mureed@obs.com.pk
ConfidentialData IntegrityMonday, April 10, 2017