The document discusses quality risk management (ICH Q9) and provides guidance on its goals, expectations, principles, tools, and methodology. The key goals of quality risk management are to prioritize risks based on their potential impact to patient safety, conduct scientific risk assessments, and ensure appropriate quality systems. The level of risk management should be commensurate with the level of risk and have a strong focus on protecting public health. It also outlines various risk management tools that can be used including FMEA, FMECA, HACCP, and provides guidance on how to initiate, conduct, and review a quality risk management process.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Almost all the regulatory bodies are expected to have Risk Based Quality System. Quality Risk and its assessment has tremendous output and benefits towards the Patient Safety.
These slides were used for a invited presentation @ Patheon Seminar – Bridgewater, NJ, 31 July 2014.
Some modification have been made to connect the dots for the audience who will review this slide-deck on the internet.
This presentation provides a very brief snap-shot of a day long training program conducted recently at a company in India. In preparing the day long training session I had asked the following questions; (1) How to effectively communicate to an audience of a group of young and bright Indian professionals in any company in India and their supervisors/management about the importance of cGMPs and QbD? (2) How do I understand their challenges, perspectives and biases? (3) How do I connect with them to share the joy of Quality by Design?
The response received has been overwhelming from the audiences in India and yesterday at the Patheon Seminar in Bridgewater, NJ. I hope you will also the see some of the important dots and the connections. How this content connects to regulatory requirements is not covered in this slide deck – it connects via ‘A, B, C, D’ to 21 CFR, Quality Systems Approach to cGMP, ICH 7, 8, 9, 10, and 11.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
Performance metrics are an essential element of the management review process.
Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal or external processes.
This presentation provides a framework for establishing right quality indicators for evaluating the performance of the quality system.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
What are the process of a well-defined Risk Assessment. When taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts.
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
Almost all the regulatory bodies are expected to have Risk Based Quality System. Quality Risk and its assessment has tremendous output and benefits towards the Patient Safety.
These slides were used for a invited presentation @ Patheon Seminar – Bridgewater, NJ, 31 July 2014.
Some modification have been made to connect the dots for the audience who will review this slide-deck on the internet.
This presentation provides a very brief snap-shot of a day long training program conducted recently at a company in India. In preparing the day long training session I had asked the following questions; (1) How to effectively communicate to an audience of a group of young and bright Indian professionals in any company in India and their supervisors/management about the importance of cGMPs and QbD? (2) How do I understand their challenges, perspectives and biases? (3) How do I connect with them to share the joy of Quality by Design?
The response received has been overwhelming from the audiences in India and yesterday at the Patheon Seminar in Bridgewater, NJ. I hope you will also the see some of the important dots and the connections. How this content connects to regulatory requirements is not covered in this slide deck – it connects via ‘A, B, C, D’ to 21 CFR, Quality Systems Approach to cGMP, ICH 7, 8, 9, 10, and 11.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
Performance metrics are an essential element of the management review process.
Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal or external processes.
This presentation provides a framework for establishing right quality indicators for evaluating the performance of the quality system.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
What are the process of a well-defined Risk Assessment. When taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts.
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceuticals
Minding Our Business: Contemplative Practices for Meeting Suffering, Comfort ...lakesidebhs
From Lakeside Behavioral Health System's Spring 2016 EAP/MHP Conferences.
This workshop is about learning to love and enjoy our work with our most complex clients while giving them some skills to love and enjoy themselves. You’ll see this means increasing our own mindfulness and self-compassion.
IBSAT is an online aptitude test conducted by The ICFAI Foundation for Higher Education. It is a Computer Based Test (CBT) and consists of multiple choice questions. IBSAT is of 2 hours duration and is aimed at testing the applicant’s ability in quantitative techniques, data interpretation, data adequacy, vocabulary, analytical reasoning and reading comprehension.
Expounds on the Principles, Steps and Execution of a proper Quality Risk Management process as eluded in the ICH QRM guidelines - Q9 as well as WHO Guidelines
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
This document will help you to understand the risk based thinking approach that has been introduced to the new revision of QMS ISO 9001:2015 as well as assist the organizations that tends to move toward implementing the new standard.
the first step is to understand what is the definition of risk! when we are going to apply this term, what are things to considered? if you thinking of establishing a specially designed procedure or form related to this term what are the main categories you should considered and how? what are the modules you shall use? ... etc.
Therefore, This document will answer ,at least, most of these questions.
Best of luck, Eng. Akram Malkawi, Amman, eng.karam@outlook.com/Mob. +962795705076
useful for pharmaceutical quality assurance students, MBA and all people including industry employee to improve knowledge about the quality risk management process
Understanding the principles and practicalities of risk assessment
Understanding risk evaluation
Selecting and implementing control measures
Monitoring and reviewing
EC Directive 89/391/EEC
IEC/ISO 31010:2009
2. Goals:
• Risk Management (priorities, resources
allocation and setting regulatory requirements).
• Science-based regulatory approaches (conduct
scientific risk assessment.
• Strong public health focus.
• Assessment and implementation of appropriate
quality management systems.
• Integrated product quality regulatory practice
(review and inspection processes).
3. The Expectations:
• The evaluation of the risk should ultimately link
back to the potential risk to the patient.
• The extent of the risk management process
should be commensurate with the level of risk
associated with the decision.
• Assembling background information and data on
the hazard, harm or human health impact
relevant to the assessment.
• A more robust data set will lead to lower
uncertainty.
4. • People who apply risk management should have
the appropriate training, skills and experience.
• The risk management process should be
appropriately documented and verifiable.
• Defining specifically the risk management problem
or question, including the assumptions leading to
the question.
• Assembling background information and data on
the hazard, harm or human health impact relevant
to the assessment.
The Expectations:
5. The Expectations
• Identifying the necessary resources, members of the
team who have the appropriate expertise, with the
leader clearly identified.
• Asking the right risk assessment questions.
• Stating clearly the assumptions in the risk
assessment.
• Assessing the quality and sufficiency of relevant
data.
• Specifying and deliverables for the risk assessment.
7. Principles
1. The evaluation of the risk to quality
should be based on scientific
knowledge and ultimately link to the
protection of the patient.
2. The level of effort, formality and
documentation of the quality risk
management process should be
commensurate with the level of risk.
8. Risk Assessment and Control
Tools:
• Basic risk management facilitation
methods (flowcharts, check sheets etc.)
• Failure Mode Effects Analysis (FMEA)
• Failure Mode, Effects and Criticality
Analysis (FMECA)
• Fault Tree Analysis (FTA)
9. Risk Assessment and Control
Tools: continue..
• Hazard Analysis and Critical Control
Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Preliminary Hazard Analysis (PHA)
• Risk ranking and filtering
• Supporting statistical tools
10. Experience or Institution based approach
• Traditionally used, as it requires.
• No factual analysis or observations.
• Biased.
Symptom Remedy
Investigative Tools:
11. Data based approach
• Scientific.
• Methodical.
• Unbiased.
Symptom Root cause Remedy
Investigative Tools:
13. Initiating a QRM Process
• Quality risk management is
systematic process designed to
coordinate, facilitate and improve
science-based decision making for the
assessment, control, communication
and review of risks to the quality of the
drug (medicinal) product across the
product lifecycle.
14. Initiating a QRM Process
• Define the problem and/or risk question,
including pertinent assumptions identifying
the potential for risk.
• Assemble background information and/ or
data on the potential hazard, harm or human
health impact relevant to the risk assessment
• Specify a timeline, deliverables and
appropriate level of decision making for the
risk management process.
15. Risk Review
RiskCommunication
Risk Assessment
Risk Evaluation
unacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
Initiate
Quality Risk Management Process
Output / Result of the
Quality Risk Management Process
RiskManagementtools
RiskManagement
Process
16. Risk Assessment
• What can go wrong?
• What is the likelihood (probability) it
would go wrong?
• What are the consequences?
• Identification of hazards, analysis and
evaluation of risks associated with
exposure to those hazards.
17. Related Terminology:
• Risk Analysis is a systematic use of information
to identify specific sources of harm (hazard) and
to estimate the risk.
• Risk evaluation compares the estimated risk
against risk criteria using a quantitative or
qualitative scale to determine the significance of
the risk.
• Risk management focuses on a reduction of
severity of harm.
• Risk acceptance is a decision to accept risk, i,e,
no additional risk control activities are necessary
at that time.
18. • Focuses on processes for mitigation or
avoidance of quality risk when it exceeds
a specified (acceptable) level. Risk
reduction might include actions taken to
mitigate the severity and probability of
harm. Processes that improve the
detectability of hazards and quality risks
might also be used as part of a risk
control strategy.
Risk Control
19. • Is the risk above an acceptable level?
• What can be done to reduce or
eliminate risks?
• What is the appropriate balance
among benefits, risks and resources?
• Are new risks introduced as a result of
the identified risks being controlled?
Risk Reduction
20. • Some types of harms, even the best
quality risk management practices might
not entirely eliminate risk. In these
circumstances, it might be agreed that
an appropriate quality risk management
strategy has been applied and that
quality risk is reduced to a specified
(acceptable) level, will depend on many
parameters and should be decided on a
case-by-case basis
Risk Acceptance
21. • The sharing of information about risk and risk
management between the decision makers
and others can communicate at any stage of
the risk management process. The result of
the quality risk management process should
be appropriately communicated and
documented. The included information might
relate to the existence, nature, form,
probability, severity, acceptability, control,
treatment, detectability or other aspects of
risks to quality.
Risk Communication
22. • The results of the risk management process
should be reviewed to take into account new
knowledge and experience. Once a quality risk
management process has been initiated, that
process should continue to be utilized for events
that might impact the original quality risk
management decision, whether these events are
planned (e.g. results of product review,
inspections, audits, change control) or
unplanned (e.g. root cause from failure
investigations, recall).
Risk Review
23. QRM Methodology
QRM supports a scientific and practical
approach to decision-making. It provides
documented, transparent and reproducible
methods to accomplish steps of the quality
risk management process based on current
knowledge about assessing the probability,
severity and sometimes detectability of the
risk.
26. Action based on RPN
RPN (Risk Priority
Number
Risk Action
RPN No.: ≤ 4 Low Not required
RPN No.: 5 – 8 Medium To be decided by
team if necessary
RPN No.: ≥ 9 High Must be done
27. Severity of Effect (S)
Severity of Effect Rating Example
No relevant
consequences.
1 No effect on
Quality, equipment.
Might have effect on
product, personnel.
2 Out of calibration of
component, loss of
Product.
Harm to people, quality
of product, damage to
equipment
3 Must be done
28. Probability of Occurrence (O)
Severity of Effect Rating Example
Very unlikely 1 Failure are very rare
(1/10000-Failure)
Unlikely 2 Failure are rare (1/1000-
Failure)
Likely 3 Failure are unknown have
experience of happening
it in past (1/100-Failure)
29. Detection Time (D)
Detection Time Rating Example
Immediately 1 In-process control with
100% Test of check.
Later 2 Periodic monitoring,
weekly checks, release
testing.
Never 3 No checks or test might
detect or identify the
failure.
30. Risk Assessment Evaluation
• Quality risk management methods and
the supporting statistical tools can be
used in combination (e.g. Probabilistic
Risk Assessment). Combined use
provides flexibility that can facilitate the
application of quality risk management
principles.
32. Anything that
has the potential
to harm patients,
product quality
or the business
(loss,
interruption,
image)
Potential threat
- chemical reaction
- manufacturing issues
- facilities and equipment
System defect
- not detected
- insufficiently prevented
- emerges by degree
Failure
- technical breakdown
- human breakdown
- extrinsic effect
hazard
Definition: Hazard
33. • Understand and influence the factors (hazards)
which impact regulators and industry business
• Create awareness and a culture
• Supports an effective pro-active behaviour
– Open factual dialogue
– Make decisions traceable and consistent
• Provide assurance
– Risks are adequately managed
– Compliance to external and internal requirements
• Recognise risks at a desired level
– Zero risk not possible
QRM- Scientific Activity
35. • Hiding risks
• Writing half the truth (e.g. in an
investigation report)
• A means of removing industry’s obligation
to comply with regulatory requirements.
• Both Companies & Inspectors have to
think and not simply follow black and
white rules.
Concerns regarding QRM
36. Say, what you do
Do, what you say
Gain experience
Improve it
Approval
Manufacture
for market
Analyse root cause:
Continuous
improvement
Update
documentation
Quality Risk
Management
(QRM)
(Risk of) Failure ?
Integrate QRM during product
life cycle
37. However, if you don’t use it,
you will not gain the benefits
Quality Risk Management is
mandatory is an expectation of EU
& PICs GMP – but ICH Q9 is not