qrm in glp from compliance to business improvement janssen pharmaceutica n.v. sandra wens global...
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QRM in GLPFrom Compliance to Business Improvement
Janssen Pharmaceutica N.V.
Sandra Wens
Global Research & Development Quality Assurance / GLPQA
June 8th, 2011
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QRM in GLP - From Compliance to Business Improvement
Introduction
• What is QRM
• GLP environment
• The changing role of QA
QRM in GLP
• How it started in GLPQA at Janssen
• QRM examples - GLP departments at Janssen
• Future of QRM
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What is QRM - What is a risk?
A risk is a future event
which may or may not occur
with (usually) an adverse effect
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Risks are pervasive
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What is QRM - What is a risk?
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How do we manage risks?
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What does risk management not imply?
• Taking more risks, less quality
• Cut down on quality
• Exclude all risks
• A new practice
• Complicated
• Additional bureaucracy
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What does risk management imply?
• Systematic process designed to improve (science-based) decision-making by gaining insight to risks (probability, impact)
• ICH Q9 – June 2006 ‘Quality risk management’
– Q9 is a quality improvement methodology
– Guidance document
– Supports science-based decision making
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What does risk management imply?
• A systematic process for the assessment, control, communication and review of risks
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RiskAssessment
RiskReview
RiskControl
QR
M T
ools
Ris
k C
om
mu
nic
ati
on
Continuous Feedback for New or
Existing Risks
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Tool example
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Voorbeeld van proces!
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What does risk management imply?
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• Know your processes
– Base oneself on facts
• Identify what’s important (through Risk Analysis)
– Patient at the centre
– Stay compliant
• Focus on what is important
• Communicate and document your decisions
• Check if it works
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Principles of QRM
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Probably mitigate the
risk
Accept the risk
Mitigate the risk
Probably accept the
risk
PROBABILITY
IMPA
CT
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Balance Risks
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ChanceSeriousness
Reward
Given all the risk factors, is the reward worth taking the risks?
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Risk management: benefits
• Improved, streamlined processes
– Processes often historically developed and benefits of certain steps not questioned anymore
• Better-founded decision-making
– Helps thoroughly analyzing and considering different alternatives
– Helps to define audit strategy (which, frequency, focus,…)
• Better focus on resources and priorities
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The GLP regulations are the most stringent of all GXPs in
defining the requirements for a QA audit program
Introduction - GLP regulations
•Protocol, Critical phases and report audits•Required for each GLP study
Study specific audits
•Inspection of GLP labs focusing on general items like equipment, labelling, SOP management
Facility audits
•Not required by regulations•Concept of system audits is introduced since about 10 years•Looks at systems that are used across studies
Process-based or System
audits
GLP Required
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The GLP regulations are the most stringent of all GXPs in
defining the requirements for a QA audit program
Introduction - GLP regulations
•Protocol, Critical phases and report audits•Required for each GLP study
Study specific audits
•Inspection of GLP labs focusing on general items like equipment, labelling, SOP management
Facility audits
•Not required by regulations•Concept of system audits is introduced since about 10 years•Looks at systems that are used across studies
Process-based or System
audits
GLP Required
Ris
k B
as
ed
Ap
pro
ac
h
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Times are changing
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Times are changing
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Past:• Easy world• Exponential growth Pharma
Industry
Now:• More complex world• Do more with less• New technologies (e-data)• New scientific development
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• Quality Risk Management
• The job of a QA professional is evolving from a standard, audit-driven, reactive process towards a proactive, customer-focused approach.
• Accelerating business growth through innovative quality solutions
The Changing Role of QA
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QRM in GLP - From Compliance to Business Improvement
QRM in GLP
• How it started
• QRM examples - GLP departments at Janssen
– QRM Case 1
– QRM Case 2
• Future of QRM
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How it started
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• 2007 • 2008• ICH Q9 Quality
Risk Management
• A few “believers” in GLPQA practiced QRM • GLPQA QRM template
was developed
• 1-day QRM workshop for global GLPQA ;
• Template + Mindset
• 2006 • 2009
• GLPQA team to identify and prioritize QRM opportunities to feed 2009 G&Os
• QRM roll outin GLP business
• 2010 - 2011
• QRM projectsin partnerschip with
• Business Partners:• Bioanalysis
department• Histology
department• PK sample
shipment• ...
4 QRM projects ongoing
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QRM 1 Bioequivalence studies
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Read study info
protocol
IdentifyValidatedMethod
CAL
Thaw,pipette,extractsamples QC and
Cals
Analyzesamples, QC and
Calsby
LC-MS/MS
internalreport
Plasma Samples
QC4-6-15
CAL15% RE
CalculateAnd
validate
QC
Weigh outDry stock
QAQAQA
Introduction – Bioanalysis workflow
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Bioanalysis protocol • Duplication of existing information
• From clinical protocol• From Bioanalysis SOPs• From Bioanalysis Method validation
• Risk to mistakes and QA observations
• Not a regulatory requirement• Heritage from the past when this was done in the form of a GLP
study
Simplify Bioanalysis
proces
Apply risk based
approach to QA audit
QRM case 1 – situation
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Alternative process No protocol, no BA number
Risk IdentificationWhat can go wrong?
QA is not aware of study
Risk assessment Probability: HImpact: M
Pro’s and con’s of each alternative
Time efficient
Risk reducing controls QA receives weekly automated report from planning database
Residual risk Probability: LImpact: M
Simplify Bioanalysis
proces
Apply risk based
approach to QA audit
QRM case 1 – FMEA Summary
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• Workload BA and QA
• Traceability BE studies
• Communication on new BE study to QA via automated Cognos report
Simplify Bioanalysis
proces
Apply risk based
approach to QA audit
QRM case 1 – Result
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• QA review of Bioequivalence studies
= Very detailed review, due to FDA focus
• Lots of QA comments with low added value• In combination with workload and strict timelines gives rise to
frustrations and tension between QA and Bioanalysis
Simplify Bioanalysis
proces
Apply risk based
approach to QA audit
QRM case 1 – Situation
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type of audit
# audits observations
no obs minor obs
total total nature
protocol 3 2 5 2 (1) receipt of samples before finalization of BA protocol (2x)
protocol am.
0 1 1 1 (1) receipt of samples before finalization of BA protocol am.
exp. phase 3 2 5 3 (1) receipt of samples before finalization of BA protocol
(1) late distribution of BA protocol
(2) confirmation of sample reception not distributed to TK scientist and GLPQA
report 0 2 2 7 (3) switch to CSTIM system was not documented clearly
(2) report/raw data inconsistency (2x)
(2) report/raw data inconsistency with BA protocol (2x)
(2) indexlist checked by 1 person in stead of 2
(2) raw data inconsistency
Analysis of observations from the Bioanalysis part of Bioequivalence (BE) studies for Beerse (january 2007 to october 2008)
(1) A bioanalytical protocol is not strictly necessary for BE studies. If no protocol is written, these observations do not have to be made.(2) These observations would also have been picked up if the BE audit would have been conducted in the same way as for a “normal” Bioanalysis study.(3) This is an exceptional situation
Simplify Bioanalysis
proces
Apply risk based
approach to QA audit
QRM case 1 – Data collection
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GLPQA review of BE studies - Risk managementA comparison was made between the items that are reviewed by the BA QC group and GLPQA for BE studies. (BA QC follows the same review process for all BA studies, GLPQA puts more effort in Bioanalysis from BE studies than in other Bioanalysis).Currently for BE studies, the following items are not reviewed by QC, only by GLPQA:
Items currently reviewed by GLPQA, not by BA QC (specifically for BE studies)
covered during other regular in life audits?
System audits?
Risk (IxP) Effort FDA focus?
Conclusion: Check during BE study?
Comments
Impact Probability Yes No
Raw data on preparation of QC samples and calibrators (freshly prepared calibration stds are reviewed by QC)
spot checks spot checks H M H Yes X Area of focus!
Personel files and training of personel involved in the study
only new employees spot checks M M (Many new temp. employees at BA)
M No (X) only for personnel that is new, that has just left,…
Validation status of computerized systems No spot checks H L L No (X) Only new systems and upgrades
LCMS logbook and PPG calibrations spot checks spot checks M L M (Yes) (X) Only in case issues are noted on STF1
Freezer logs No spot checks L (alarms generated before impact on samples
L M Yes X System audits show that a robust system is in place
Labelling and condition of samples study specific (sporadically)
spot checks M (follow up by BA support) L M No X
Calibration/control of pipettes, balances, pH meters
spot checks spot checks L L H No X
Preparation of buffers and reagents spot checks spot checks M L H No X
Simplify Bioanalysis
proces
Apply risk based
approach to QA audit
QRM case 1 – Risk ranking
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• Workload QA (about 40% (from 8 to 5 working days))
• Compliance level remains high
Simplify Bioanalysis
proces
Apply risk based
approach to QA audit
QRM case 1 – Result
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QRM 2 Bioanalysis in preclinical studies
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• Study specific audits– For each Bioanalysis study (part)
• Protocol audit• At least 1 experimental phase audit• Report audit
– Overlap between experimental phase and report audits
– Audit approach and focus differs between auditors
• 1 Bioanalysis system audit every 2 years– Extensive scope (covers all processes from sample
reception till reporting of results)
• QA and QC alignment can be improved
Optimize QA auditprogram
Align QA and QC efforts
QRM case 2 – Situation
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•Type of audits
•Timing•Frequency•Scope•Focus
Optimize QA auditprogram
•Ensure that critical process steps are covered with correct focus ad minimal overlap
Align QA and QC efforts
QRM case 2 – Scope
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• Multidisciplinary team
– QA
– Bioanalysis• Lab technician• QC person• Support group representative
Optimize QA auditprogram
Align QA and QC efforts
QRM case 2 – Approach: Who?
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Process excellence and QRM tools
– Define• Project charter + business case
• Stakeholder analysis + communication plan
• Voice of the Customer (QA + Bioanalysis)
– Measure• Process mapping
• Define Customer needs (CTQs)
• Priority matrix
• Data collection plan
– Analyse• Analyse data -Brainstorm and rank solutions (QRM)
– Innovate and Improve• Implementation plan
• Develop metrics
– Control• Monitor metrics
Optimize QA auditprogram
Align QA and QC efforts
QRM case 2 – Approach: How?
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• BA and QA outcome in good agreement
– System audit• High added value• Multidisciplinary team• Focus on processes
– Experimental phase audits• Low added value • QA audit takes place before QC review• Overlap with report audit
– Not sure if all critical steps are covered adequately by QC/QA.
Optimize QA
auditprogram
Align QA and QC efforts
QRM case 2 – VOC results
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–Focus on critical aspects–Minimal overlap with QC review –Minimal overlap with different types of QA audit
–Maintain High compliance level –More focus on processes
Optimize QA
auditprogram
Align QA and QC efforts
QRM case 2 – Define customerneeds
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Priority matrix
Study-specific audits Output variables Focus on critical
aspectsMinimal overlap with QC review
Minimal overlap with different types of QA audit
High compliance level
More focus on processes
Total
Weight (1-10) 10 5 5 3 8 Input and process variables Checklists 9 9 9 1 5 232Training 9 5 5 5 9 227Timing 5 5 0 1 0 78Inspection reports 0 0 0 5 0 15Raw data and report 0 0 0 9 0 27Bioanalysis processes (SOPs) 5 0 0 9 1 85QA program 1 0 5 9 9 134Bioanalysis planning 0 0 0 0 0 0Bioanalysis equipment 0 0 0 5 0 15Protocol 0 0 0 0 0 0Regulations 5 0 0 9 0 77Corrective actions 0 0 0 5 0 15QAAD 0 0 0 0 0 0QC process 0 0 0 5 0 15Bioanalysis email (start analysis) 1 0 0 0 0 10Auditor 9 5 5 5 9 227Analyst 0 0 0 9 0 27# samples 0 0 0 0 0 0# batches 0 0 0 0 0 0Method validation (raw data) 0 0 0 9 0 27Method 1 0 0 9 0 37Bioanalysis Systems (Watson and Analyst) 0 0 0 5 0 15
Legend: relationship between output and input/process variables0 = no relationship1 = weak relationship5 = moderate relationship9 = strong relationship
Checklists and training for auditors!
Optimize QA
auditprogram
Align QA and QC efforts
QRM case 2 – Priority matrix
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Analysis of Bioanalysis Audit findings from last 2.5 years
Optimize QA auditprogram
Align QA and QC efforts
QRM case 2 – Data analysis
parameter Experimental phase audits
System audits
Number of audits
125 1
Number of observations
17 15
Total working days
60 10
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• 1 system audit to be subdivided in different smaller system audits with frequency depending on risk factors such as criticality of process and previous audit findings
• Decreased number of experimental phase audits
• Enhanced checklists for study specific reviews by QA and QC
– Minimal overlap between different QA/QC checks
– Cover critical aspects with correct focus
Optimize QA
auditprogram
Align QA and QC effortsQRM case 2 – Result
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• Better focused audit program to areas of greatest risk
• Efficient use of resources
• Better collaboration/appreciation by business partners
• Maintain and enhance high compliance level
Optimize QA
auditprogram
Align QA and QC effortsQRM case 1 + 2 Results
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We believe that a customized implementation of risk management and process excellence tools, embraced by both QA and business partners, will accelerate business growth through innovative quality solutions.
Conclusion
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Examples of projects
• Are all critical activities of study performance
– Documented, Adequately documented or Documented exaggerated
• Harmonization documentation practices: different practices within one test facility
– Rodents versus Non-rodents
• Review of documents/processes
– Quality Assurance versus Quality Control
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Future of QRM?
• QRM already established in a lot of other branches of industry
• QRM in GxPs:
– FDA cGMP’s
– ICH Q9
– FDA GLP (21 CFR part 58) modernization
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It is not necessarily the strongest that survives, nor the most intelligent, but the one most responsive to change.
(Darwin, 1809-1882)
Mitigating risk requires a different mindset than ensuring quality
Future of QRM?
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Thank You