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CRP 112 Audits > CRP 112 Lecture 4 > Flashcards

CRP 112 Lecture 4 Flashcards

1
Q

TransCelerate

A

-Non-profit
-Goal to improve health of people around the world by simplifying & accelerating R&D of innovative new therapies
-identify, prioritize, design
implementation of solutions for efficient, effective and high-quality delivery of new medicines worldwide
Has own cQMS (clinical quality management system) initiatives
 Shared investigator platform
 Clinical Research Awareness and Access
 Comparator network

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2
Q

QMS

A

In pharma manufacturing
 Standardized
 ICH Q10: Pharmaceutical Quality System
 ICH Q9: Quality Risk Management
 In clinical
 Fragmented
 No industry wide conceptual framework for
clinical QM

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3
Q

ICH Q10: Pharmaceutical Quality System objectives

A
  1. Achieve product realisation
     Product is delivered to meet patient needs
  2. Establish & Maintain a State of Control
     Continued suitability & capability of processes – risk mgt
  3. Facilitate Continual Improvement
     Use quality risk management
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4
Q

ICH Q10

A

-For systems supporting development & manufacture of
- Pharmaceutical drug substance (API)
- Drug products, including biotechnology & biological products
-Applies throughout product lifecycle (development, tech transfer between development and manufacturing, commercial manufacturing, product discontinuation)

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5
Q

ICH Q10 Management
Responsibility

A

 Management commitment
 Quality policy & quality planning
 Resource management
 Internal communication
 Management review
 Management of outsourced activities & purchased materials
 Management of change in product ownership
 CAPA
 Change Management System
 Management review of process
performance & product quality

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6
Q

ICH Q10 Product Quality
Monitoring

A

 Monitoring system to ensure state of control is
maintained
 Process performance & QMS
 Use quality risk management (ICH Q9)
 Provide tools to measure & analyze
 Analyze parameters & attributes
 Provide feedback on product quality

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7
Q

ICH Integration: Q8, Q9, Q10

A

 Q8 Pharmaceutical Development
 Q9 Quality Risk Management
 Q10 Pharmaceutical Quality Systems
 Together they encompass:
 Quality by Design, Risk Management & Product Quality System

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8
Q

ICH Q9: Quality Risk Management principles

A

2 primary principles
 Base risk evaluation on scientific knowledge & link
to patient protection
 Effort, formality & documentation is based on level of risk

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9
Q

ICH Q9(R1): Risk Assessment

A

 Hazard ID
 Risk Analysis (likelihood and severity of consequences)
 Risk Evaluation

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10
Q

ICH Q9(R1): Risk Control

A

 Reduce or accept risks
 Effort to reduce risk must be proportional to significance of risk

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11
Q

ICH Q9(R1): Risk Communication

A

 Sharing information about risk & risk
management
 Occurs at any stage of process
 Output/result of quality risk management
process should be communicated AND
documented

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12
Q

ICH Q9(R1): Risk Review

A

 Review output/results to take into account new knowledge and experience
 Once initiated, continue for events that might impact original quality risk
management decision
 Planned or unplanned events

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13
Q

cQMS Definition

A
  • Currently no cQMS guidance
     Integrated approach for an organization to systematically:
     Define quality objectives taking into account both strategic objectives & regulatory requirements
     Develop & Implement infrastructure
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14
Q

Advantages of a cQMS

A

 Sites:
 By focusing on “errors that matter”, it decreases burden and streamlines the processes
 Sponsors:
 Fewer delays due to reduced remediation associated with quality issues
 Better ability to solve repetitive quality issues
 Regulators:
 Gives them consistent quality framework to evaluate, especially during inspections
 Participants:
 Increased participant safety
 Focus on “errors that matter” to well being & safety of participants

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15
Q

Foundational aspects of a cQMS (4)

A

-Understanding the Context
-Leadership Commitment to Quality
-Organizational Commitment to Quality
-Continuous Improvement of clinical QMS

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16
Q

cQMS Understanding the Context

A
  • Evaluate external & internal environments
  • Political, economic, social, regulations,
    market structures, trial designs etc.
  • Internal governance, organizational
    structure, roles, policies, culture,
    corporate knowledge etc.
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17
Q

cQMS Leadership Commitment to Quality

A

 Sr. management is accountable & responsible for defining expectations for quality AND communicating the importance of quality
 Each employee should understand how quality applies to them & other stakeholders

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18
Q

cQMS Organizational Commitment to Quality

A

 Sr management needs to cultivate an
environment where everyone takes ownership of quality and holds themselves and others accountable for quality
 Organization should empower individuals to
address quality concerns without fear of reprisal

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19
Q

cQMS Continuous Improvement of clinical QM

A

 Organization monitors internal/external context for changes that might necessitate modification of the QMS
 Leverage outputs from knowledge management activities
 Conduct internal audits
 Ensure appropriate change management is used

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20
Q

Elements of a cQMS (7)

A

-Processes
-Resources, Roles, Responsibilities
-Partnering
-Risk Management
-Issue Management
-Knowledge Management (KM)
-Documentation

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21
Q

cQMS Processes

A

 Well defined and characterized
 Develop clear/concise documents (e.g. SOPs)
-Instill Knowledge Management Activities (identify changes that mean re-evaluation of
processes & associated documents)
 Consider burden of implementation
 Determine which processes/documents mandatory, which are best practices
 Training

22
Q

cQMS Resources, Roles, Responsibilities

A

 Prospectively evaluate required resources & skill-
sets to achieve clinical strategy
 Ensure appropriate resources are available
 Ensure clarity in roles, responsibilities &accountability
 All staff to be qualified (education, training, experience)

23
Q

cQMS Partnering

A

 Co-development and outsourcing (i.e. Sponsor and CRO agreement)
 Prospectively consider for all parties:
 Needs
 Expectations
 Limitations
 Risks
 Ownership must be taken by each party
 Prospectively document agreement on:
 Expectations for how activities are conducted
 Communications (including escalations)
 Performance measurement

24
Q

cQMS Risk Management

A

Types of Risk
 Strategic (Licensing opportunities, partnership benefits)
 Operational (IP productions)
 Quality (Endpoint criteria, data credibility)
 Compliance (Regulatory requirements for registrations)

25
Q

“Plan Do Check Act” (PDCA) cycle

A

referred to in ISO 31000 – Risk Management
-policy and government
-program design
-implementation
-monitoring and review
-continual improvement

26
Q

ISO 31000 – Risk Management

A

 Helps account for unexpected when managing risk
 Will identify & analyze risks in organizational context
-Active communication, process eval, oversight

27
Q

Clinical trial context Significant risks

A

 Participant safety
 Data integrity
 Regulatory compliance
 Trust in organization

28
Q

Risk Management Process

A
  1. Understanding the context
    -Identify changes (Internal and External) that might create risks
  2. Risk Assessment
    -ID, analyze (level), evaluate (likelihood, impact, effectiveness of existing mititgations)
  3. Risk Mitigation
    -ID actions to address the risk (accept, avoid, transfer or reduce)
  4. Risk Monitoring and Review
    -Did actions achieve desired outcome?
    -Periodically assess changes in internal or external context
  5. Communication and Consultation
    -Include all stakeholders
    -Include regulatory authorities when applicable
    -Occurs at all stages of process
29
Q

cQMS Issue Management

A

 Issues that Matter
 Supports effective CAPA process
 Issue documentation & investigation
 Trending and Analytics

30
Q

cQMS Knowledge Management (KM)

A

 Getting right information to right people at the right time
 Ensure key prior knowledge is accessible to entire team
Types of knowledge:
Explicit
 Visible – easily recognized,
shared, documented & assessed
Tacit
 Experience of team members
 Goal is to collaborate and communicate – exchange
and maintain knowledge

31
Q

cQMS Documentation

A

 Level of documentation Commensurate with risk level, significance of activity and meeting stakeholder requirements
-Supports the achievement of Quality

32
Q

ACRO QMS

A

-building on TransCelerate
-Sourcing models: Fully Outsourced, Internalized Model (Sponsor has direct visibility into activities), or Hybrid Approach (Shared environment aka Functional Service Provider (FSP) Relationship)

 Greater visibility into risk management
process & observations
 Removal of emotional decisions
 Data driven decisions instead!
 Pro-active, collaborative oversight model

33
Q

ACRO QMS Components

A

Knowledge Management
Risk Management
ID & mitigate risks that impact the 2 things+1!
 Participant safety
 Data quality & integrity
 Plus regulatory compliance
Issue Management, Focus on Issues that Matter
Roles & Responsibilities
Technology
Quality Metrics (Key Risk Indicators (KRIs), Quality Tolerant Limits (QTLs), Key Performance Indicators (KPIs))
Policies/Procedures for CRO

34
Q

Building Quality into Clinical Trials

A

 Quality cannot be monitored, audited, or inspected
retrospectively
 At the trial level, the protocol – or
investigational plan - is the blueprint for quality

35
Q

ICH

A

International Council for Harmonisation

36
Q

ICH E6(R3)

A

Designing quality in clinical trials
Stakeholder engagement
Trial design
Proportionate trial management
Focus on factors critical to quality
of trials
-new study designs, conduct, technologies and data sources
ICH E8(R1) - designing quality into clinical studies

37
Q

ICH E6(R3) Step 3 Stages

A

Stage I - Regional regulatory consultation
Stage II - Discussion of regional consultation comments
Stage III - Finalisation of Step 3 Experts Draft Guideline

38
Q

ICH E6(R3) Principles

A

Guideline is intended to be media neutral to enable use of
different technologies
- encourages thoughtful consideration & planning to address aspects of CTs to ensure trial quality
-Digital health technologies
-variety of relevant data sources
-Keep clinical trial conduct in line with advancing science &
technological developments
-Adapt use of technology to fit participant characteristics &
particular trial design
-Quality should be built into scientific &
operational design/conduct of CTs
Prospectively manage risks to Critical to Quality
-Computerised systems must be Fit
for Purpose addressing factors Critical to Quality
-Transparency by registration & public posting of results.

39
Q

ICH E6 (R2) – Quality Risk Management

A

Quality management includes:
 efficient design of clinical trial protocols
 data collection & processing tools & procedures
 collection of information essential to decision making
 Quality management system should use a risk-based approach

40
Q

Sponsor: Quality Management

A

Sponsor should implement a system to
manage quality throughout all stages of the trial process, focus on participant protection and reliability of trial results
Quality management includes:
 efficient design of clinical trial protocols
 data collection & processing tools & procedures
 collection of information essential to decision making
-all aspects of trial are
operationally feasible
-Protocols, CRFs, & other operational documents should be clear, concise & consistent
-Quality management system should use a risk-based approach

41
Q

Risk based approach (7)

A

-ID critcal processes and data
-ID risks
-risk eval
-risk control
-risk communication
-risk review
-risk reporting

42
Q

Critical process and data identification

A

During protocol development, sponsor should
identify those processes & data that are:
 critical to assure human participant protection & reliability of study results

43
Q

Risk identification

A

Risks should be considered at both:
 system level (e.g. standard operating procedures,
computerized systems, personnel) &
 clinical trial level (e.g. trial design, data collection &
informed consent process)

44
Q

Risk evaluation

A

Identified risks should be evaluated vs.
existing risk controls by considering:
 Likelihood of errors occurring
 Extent to which such errors would be detect
 Impact of errors on human participant protection &
reliability of trial results

45
Q

Risk control

A

Sponsor should decide which risks to:
 Reduce and/or accept
 Approach used to reduce risk to an
acceptable level should be proportionate to significance of risk
 Predefined quality tolerance limits should be established
 Detection of deviations from predefined quality tolerance limits should trigger an evaluation to determine if action is needed

46
Q

Risk communication

A

QM activities should be documented &
communicated to those involved or
affected
facilitate:
 risk review & continual improvement during clinical trial execution

47
Q

Risk review

A

Sponsor should periodically review risk
control measures to ascertain whether
implemented quality management activities remain effective and relevant
 Take into account emerging knowledge & experience

48
Q

Risk reporting

A

Sponsor should
-describe quality management approach implemented in trial
- summarize important deviations from predefined quality tolerance limits and remedial actions taken

49
Q

TransCelerate Risk Assessment and Categorization Tool (RACT)

A

Provides categories of risk, questions for discussion & considerations specific to risk categories (i.e phase, complexity, population, tech, CRF source, endpoints, IP etc)

50
Q

RACT considerations

A

Impact (1-3)
 Data integrity, participant safety, GCP compliance
Probability of occurring (1-3)
 High, medium or low probability
Detectability (3-1)
 Higher detectability is lower risk (easy to detect =1)

CRP 112 Audits (9 decks)

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