20181101 RQA Data Integrity & Risk by Ian Ramsay

www.RamsayPharma.com
www.MHRADeficiencies.com
Ian.Ramsay@Ramsaypharma.co.uk
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21 October 2018
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Data Integrity & Risk
A Proportional Approach To Data Integrity
©RamsayPharma 2018

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21 October 2018
©RamsayPharma 2018
Introduction & Bio
 Independent Quality Consultant with over 14 years experience across a
range of dose forms, technologies and manufacturing sites.
 7 years with Big-Pharma offering a range of support, coaching and
oversight to multiple manufacturing sites world-wide
 4 years with MHRA (UK Regulator) performing regulatory inspections &
compliance management to wide range of manufacturers world-wide
(sterile/non-sterile/licensed/unlicensed/IMPs/Biologic)
 Consulting for industry. Support, Remediation & Audits
 Actively curate MHRA Deficiencies- an upcoming website trending MHRA
deficiencies for industry

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Disclaimer
 All opinions represented here are my own and only my own
 No offence is intended in anything I’m about to say!
 This is a complex topic- you cannot get all the answers in 30 mins!
 Strongly recommend you seek a diverse range of opinions
 Will assume a level of Data Integrity Understanding
 I am not a lawyer and I am not giving any form of legal advice (this will
become relevant later!)
©RamsayPharma 2018 3

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Purpose & Scope
 Purpose:
 “Is the tail wagging the dog”?
 Has Data Integrity lost all senses of
proportionality?
 What is the actual risk?
 What can be done to address this issue?
 Scope:
 Data Integrity concerns & issues in a GxP setting
©RamsayPharma 2018

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Data Integrity Background
©RamsayPharma 2018
Complex Topic Simple Principals
Broad Scope Continuing Problem

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Data Integrity
Background
 Regulators have developed excellent
guidance on the topic
 Increasing focus on the quality culture
 Increasing focus on the driving factors
behind fraud/falsification
 Heavy emphasis on pressure applied to
individuals and people in the business
 However…..determining whether an issue is
deliberate falsification or a simple error is
very difficult
 Principal Determining factor is INTENT
 Difficult to determine Intent

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Data Integrity Background
 Principally, Data Integrity focus is designed to prevent deliberate
falsification/fraud
©RamsayPharma 2018
Bad Practice
• Not intention to deceive
• No intention to harm
• No intention to benefit
Falsification
• Deliberate deception
• No intention to harm (most of the time!)
• Pursuing a perceived or actual benefit
• Hiding a perceived or actual weakness
• Often driven by:
• Opportunity
• Motivation
• Reward
Top Priority!
80% of the
issue
20% of the
issue
VS
INTENT

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21 October 2018
Data Integrity
Background
 Inability of regulators to
effectively evaluate intent makes
it hard to evaluate a data
integrity issue
 Difficulty in determining intent
leads to an assumption that any
DI issue is deliberate and/or
falsification
 Companies often left to prove
their innocence- very challenging
 Resources being diverted to
manage low risk events because
they are not fully understood
 Other critical areas often suffer
as a result

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What Do We
Need?
 A mechanism or framework for more
effectively evaluating data integrity
issues
 A mechanism or framework for
prioritising data integrity issues
according to risk
 A process for determining Intent much
more effectively
 Get regulator buy-in
 Prioritise what's important
 Don’t forget the rest of the business
 Reintroduce proportionality to Data
Integrity
Help Determine Intent

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©RamsayPharma 2018

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What Do We Need?
 Good News!......we don’t have to reinvent
the wheel here
 Criminal justice has been thinking about
this topic for hundreds (if not thousands) of
years
 There is an established approach to
classifying intent and degrees of deliberate
action
 Often referred to as “Mens Rea” in common
law jurisdictions
 Establishes a widely accepted framework
for determining the level of intent in any
misdeed 11

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Mens Rea as a Model For Determining
Intent
©RamsayPharma 2018
Increasing
Level of
Intent

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Intent
 Direct Intention:
 The individual/group/company wants something to happen and deliberately sets
out to make sure that thing happens
 For example: a deliberate falsification of batch records to avoid criticism related
to an out of range value
 For example: a deliberate manipulation of an HPLC result to hide the fact it was
originally out of specification
 Indirect or “Oblique” Intention:
 The individual/group/company does not specifically intend for the consequence of
their action, however are virtually certain that is may happen or is a possibility
 For example: deliberately manipulating all HPLC chromatogram integration to
ensure their chance of passing is increased (although not knowing of OOS)
 For example: deliberately replicating a paper record to remove errors or mistakes
and make the record seem “cleaner”
©RamsayPharma 2018

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Intent
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Direct
Intention
Oblique
Intention
Deliberate, wilful
and targeted
falsification
Deliberate
falsification,
usually untargeted
Deliberate bad practice-
indication of poor training &
culture
Unconscious/non-deliberate
bad practice- indicate of
poor training or systems

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Mens Rea as a Model
For Determining Intent
 Any issue must be fully investigated
 The investigation must include discussions with those
involved- even if they are implicated
 Hard and often difficult discussions will need to be
undertaken
 Establish a range of questions which can help to
differentiate actions between the different levels of
“Mens Rea”
 Look beyond the words- look at possible motives
 Benefits obtained
 Perceived of actual weaknesses hidden
 Pressures on the individuals
 Remember the Pressure/Opportunity/Rationalisation
model
©RamsayPharma 2018

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EU GMP Risk Levels
 We must remember patient risk as well!
 Potential risk to the Patient/Product/Process
is key
 Regulators follow very clearly defined rules
regarding classification of deficiencies
 EMA Community procedures define the rules
for regulators and outlines the classification
definitions for deficiencies
 Available online at EMA under “ Compilation
of Community Procedures on Inspections and
Exchange of Information”
 EMA/572454/2014 Rev 17
©RamsayPharma 2018

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A Potential Model for Data Integrity Risk
Evaluation
 Combine the principals of the EU community procedures with the concepts
and principals of “Mens Rea” & Intent
 Re-establish proportionality in evaluating Data Integrity issues
 Provide a clearly defined framework for considering intent when determining
risk
 Reduce the number of critical deficiencies and findings which have no patient
risk
 Re-establish a risk based approach to this complex topic
 Drive consistency through the industry and our regulators
©RamsayPharma 2018

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A Potential Model for Data Integrity Risk
Evaluation
©RamsayPharma 2018
Intent & Criticality Deficiency Risk Matrix
Deficiency Risk
Other Major Critical
LevelofIntent
Purposely Critical Critical Critical
Knowingly Major Major Critical
Recklessly Minor Major Critical
Negligently Minor Major Critical

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21 October 2018
Summary &
Conclusions
 Data integrity is a complex topic
 Data Integrity is not going away
 Ultimately, falsification is a Human Issue-
dependent heavily on INTENT
 Intent can be driven by many things, however
pressure is key (remember pressure,
opportunity and rationalisation)
 It is very important to establish the level of
intent when determining the risk of any data
integrity event
 Purposeful & Knowing falsification should be
the key focus:
 Purposeful actions are the most
important- indicating deliberate
falsification with an intended outcome
 Knowing actions indicate deliberate
falsification but with no specific outcome
intended
©RamsayPharma 2018

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Summary &
Conclusions
 Establishing a PROPORTIAL approach to data
integrity findings is key
 Regulators need Industry to take the lead
 Influence your regulators
 Establish detailed procedures for how to
handle and investigate issues before they
happen
 Ensure you have detailed, pre-defined
questions and topics to explore
 Summarize your overall controls on Data
Integrity (Governance)
 Document everything and make your case
regarding the risk
 Don’t neglect other parts of your operations
 Don’t ignore other risks

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Thanks You!
Q&A
 Thanks!
 I welcome any questions…..remember...we as an industry need to discuss this
topic!
©RamsayPharma 2018

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RamsayPharma Details
 Ian Ramsay available at:
 Ian.Ramsay@RamsayPharma.co.uk
 Work extensively in Data Integrity
 Work on Consulting, remediation, Audits and more….
 www.RamsayPharma.com
 Working on a new, highly searchable database of MHRA deficiencies worldwide
 Currently have over 7000 MHRA findings in specific detail
 Watch this space……
 www.MHRADeficiencies.com
©RamsayPharma 2018

20181101 RQA Data Integrity & Risk by Ian Ramsay

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