The document discusses quality risk management in the pharmaceutical industry. It defines key terms like risk, hazard, harm, and provides an overview of the quality risk management process. This includes risk assessment, analysis, evaluation, control, communication, and review. It also discusses tools that can be used for risk management like FMEA and benefits of implementing quality risk management. The document is from Tehran University of Medical Sciences School of Pharmacy and provides guidance on applying a systematic approach to quality risk management.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
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
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
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
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
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
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
The chance (or probability) that a problem will occur and
The result (or impact) if that problem occurs is known as Risk.
Risk cannot be eliminated, only reduced.
Risks are meant to be taken.
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.
Presentation given by Dr. Rune Moen from DNV at the annual conference of the Norwegian Society for Quality and Risk Management. The presentation focuses on how to integrate Quality and Risk Management, and how to make the integrated management system operational.
Risk Based Quality Management System AuditingAQSS-USA
All organizations have challenges in their businesses, But these internal and external challenges pose a threat to our goals and risk of their nonfulfillment.
Traditional approaches to quality and risk management involve quality gates, change control boards, feature freeze and code freeze milestones, and independent QA or Test groups. These approaches stabilize quality at by sacrificing agility.
Yet buggy fragile code is even more dangerous for Agile teams where so much is changing so often. Quality and risk management are critically important for agility.
This leads to the inevitable question: if the traditional approaches to quality and risk management don't work in an Agile context, what does?
Practices vary across organizations, but all successful teams emphasize the same underlying principles of fast feedback, high visibility, collaboration, and alignment. This talk examines various approaches Agile teams have taken to increase quality, mitigate risk, and ultimately ensure they are delivering the highest possible value for their stakeholders.
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.
TGA quality risk management requirements from July 1st 2010PharmOut
From July 1st 2010, the Australian Therapeutic Goods Administration (TGA) adopted the PIC/S GMP guide.
The PIC/S GMP guide includes Annnex 20 - Quality Risk Management, which is an adoption of ICH Q9.
This presentation discusses what the GMP code requires of pharmaceutical and other manufacturers in terms of quality risk management.
useful for pharmaceutical quality assurance students, MBA and all people including industry employee to improve knowledge about the quality risk management process
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
Risk assessment and management during food preparationaleeban_irasna
About the challenges reagarding food safety,risk analysis, risk assessment and principles of food safety management in food industry. Also contains the case study of Listeria monocytogenes in Deli meats
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
1. Tehran University of Medical
Sciences
School of Pharmacy
Quality Risk Management
Risk Analysis
Or in more general terms:
Quality Risk Management
March 2014
2. Quality Risk Management
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Quality Relationship
Quality Management
Quality Assurance
GMP
Production and Quality Control
3. Quality Risk Management
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Quality Relationship
GMP
(Good Manufacturing Practices )
Is the part of quality assurance that ensures that products are
produced and controlled consistently and reliably.
It can only come about by having clear descriptions of the way
in which the work will be done.
GMP specifically addresses risks that cannot be fully controlled
by testing of the final product:
•Cross-contamination
•Mix-ups
These risks can best be controlled by having a properly
managed system of working that takes them into account.
Quality Management
Quality Assurance
Production and Quality Control
4. Quality Risk Management
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Quality Relationship
Quality Management
ICHQ10:
Pharmaceutical
Quality SystemQ7:
GMP
Q8:
Pharmaceutical
Development
Q9:
QRM
5. Quality Risk Management
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INTRODUCTION
• Risk management is not new – we do it informally all
the time
• Risk management principles are effectively utilized in
many areas of business and government.
• Military Standard 1629 dated 1974 regarding formal
risk management
• Risk management has been used in the medical device,
telecommunications, aerospace and car industries for
many years.
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INTRODUCTION
ISO 31000:2009 Principles (Clause 3) Risk management
should….
1.Create value
2.Be an integral part of organizational processes
3.Be part of decision making
4.Explicitly address uncertainty
5.Be systematic and structured
6.Be based on the best available information
7.Be tailored
8.Take into account human factors
9.Be transparent and inclusive
10.Be dynamic, iterative and responsive to change
11.Be capable of continual improvement and enhancement
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INTRODUCTION
• Managing risk means forward thinking
• Managing risk means responsible thinking
• Managing risk means balanced thinking
• Managing risk is all about maximizing opportunity and
minimizing threats
• The risk management process provides a framework to
facilitate more effective decision making
Quality by Design
Risk Management is about making value
out of uncertainty
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Risk Management in Pharma. Industry
• From a GMP point of view, we are only concerned with
risks associated with quality, safety and efficacy
Quality Risk Management
• Organisations use risk approaches in other areas, e.g.
to ensure resources are utilised in the most effective
way.
Patient Safety
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DEFINITIONS
• Harm: Damage to health, including the damage that can occur
from loss of product quality or availability.
• Hazard: The potential source of harm
• Risk (In Pharmaceutical POV): The combination of the
probability of occurrence of harm and the severity of that harm.
• Risk (In General – ISO31000): effect of uncertainty on objectives
– An effect is a deviation from the expected — positive and/or negative.
– Objectives can have different aspects (such as financial, health and safety, and
environmental goals)
– Uncertainty is the state, even partial, of deficiency of information related to,
understanding or knowledge of, an event, its consequence, or likelihood.
– Risk is often expressed in terms of a combination of the consequences of an
event (including changes in circumstances) and the associated likelihood of
occurrence.
EVENT! EVENT!
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Principles
• Two primary principles of quality risk
management are:
– The evaluation of the risk to quality should be based
on scientific knowledge and ultimately link to the
protection of the patient; and
– The level of effort, formality and documentation of
the quality risk management process should be
commensurate with the level of risk.
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QUALITY RISK MANAGEMENT PROCESS
• Quality risk management is a systematic process
for the assessment, control, communication and
review of risks to the quality of the medicinal
product across the product lifecycle.
12.
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Responsibilities
• Quality risk management activities are usually,
undertaken by interdisciplinary teams.
• CFTs may include experts from the appropriate
areas e.g., quality unit, business development,
engineering, regulatory affairs, production
operations, sales and marketing, legal, statistics
and clinical in addition to individuals who are
knowledgeable about the quality risk
management process.
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Risk Assessment
• A systematic process of organizing information
to support a risk decision to be made within a
risk management process.
• It consists of the identification of hazards and
the analysis and evaluation of risks associated
with exposure to those hazards.
1. What might go wrong (Identification)?
2. What is the likelihood (probability) it will go wrong?
3. What are the consequences (severity)?
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Risk Assessment
• Risk identification
– Use of information to identify hazards or potential risks
– Historical data, theoretical analysis, informed opinions
• Risk analysis
– Estimation of risk associated with identified hazards
– Qualitative or quantitative
– Links probability and severity
– In some tools, includes detectability
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Risk analysis
Probability Severity Detectability
Likely to
occur
High
(4)
Serious GMP non-
compliance
Patient injury possible
Critical
(10)
An specific
detection System or
Indicator exists
Easily
Detectable
(0.75)
May occur
Medium
(3)
Significant GMP non-
compliance
Impact on patient
possible
Moderate
(5)
No specific
detection system
but can be
detected on daily
inspections
Moderate
Detectability
(1)
Unlikely to
occur
Low
(2)
Minor GMP non-
compliance
No patient impact
Minor
(1)
May be detected
accidentally
Probably
Detectable
(1.25)
Very
unlikely to
occur
Remote
(1)
No mentionable
Impact
None
(0)
Un-detectable Hardly
Detectable
(1.5)
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Risk Evaluation
• Risk evaluation
– Compares identified and analysed risk against criteria
– Considers probability, severity and detectability
– Output can be qualitative (high, medium or low)
– Output can be quantitative (probability x severity x
detectability)
– Quantitative provides a relative ranking – prioritises risk
Risk = Probability x Severity x Detectability
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Risk Evaluation
• Risk definitions:
Based of Quantitative or Qualitative outputs, Risks are
categorized as follows:
Intolerable – work to eliminate the negative event or
introduce detection controls is required as a priority
Unacceptable – work to reduce the risk or control the
risk to an acceptable level is required
Acceptable – the risk is acceptable and no risk
reduction or detection controls are required
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Risk Control
• Risk control includes decision making to reduce
and / or accept risks.
• The purpose of risk control is to reduce the risk
to an acceptable level.
• The amount of effort used for
risk control should be
proportional to the
significance of the risk.
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Risk Control
• Risk control might focus on the following
questions:
1. Is the risk above an acceptable level?
2. What can be done to reduce or eliminate risks?
3. What is the appropriate balance among benefits,
risks and resources?
4. Are new risks introduced as a result of the
identified risks being controlled?
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Risk Control
• Risk reduction
– Actions taken to lessen the probability of occurrence
of harm and the severity of that harm
– Typically CAPA and change control
• Risk acceptance
– The decision to accept risk
– If risk reduction action taken, follows re-analysis and
evaluation
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Change Control Vs. Risk Management
Change
Control
Risk
Management
OUTPUT /INPUT
Risk Assessment
Risk Control
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Risk Communication
• Risk communication is the sharing of
information about risk and risk management
between the decision makers and others.
• Parties can communicate at any stage of the risk
management process
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Risk Review
• Risk management should be an ongoing part of the quality
management process.
• Review or monitoring of output/results of the risk
management process considering (if appropriate) new
knowledge and experience about the risk
– Ensures nothing has changed to affect the QRM
assumptions, output and conclusions
– Consider during product review
• The frequency of any review should be based upon the level
of risk.
• Risk review might include reconsideration of risk
acceptance decisions
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RISK MANAGEMENT METHODOLOGY
• Quality risk management 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.
• Traditionally, risks to quality have been assessed and
managed in a variety of informal ways based on, for
example, compilation of observations, trends and other
information.
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Risk Management Tools
• Pharmaceutical industry and regulators can assess and manage
risk using recognized risk management 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);
– Hazard Analysis and Critical Control Points (HACCP);
– Hazard Operability Analysis (HAZOP);
– Preliminary Hazard Analysis (PHA);
– Risk ranking and filtering;
– Supporting statistical tools.
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FMEA as an example
• Failure Mode and Effects Analysis (FMEA) was one of the first
systematic techniques for failure analysis.
FMEA
Ref.
Item Potential
failure mode
Potential
cause(s) /
mechanis
m
Mission
Phase
Local
effects of
failure
Next
higher
level
effect
System
Level End
Effect
(P)
Probabilit
y
(estimate)
(S)
Severity
Detection
(Indicatio
ns to
Operator,
Maintaine
r)
(D)
Detection
Dormancy
Period
Risk Level
P*S (+D)
Actions
for further
Investigati
on /
evidence
Mitigation
/
Requirem
ents
1.1.1 Brake
Manifold
Ref.
Designator
2b, channel
A, O-ring
Internal
Leakage
from
Channel A
to B
a) O-ring
Compress
ion Set
(Creep)
failure b)
surface
damage
during
assembly
Landing Decrease
d
pressure
to main
brake
hose
No Left
Wheel
Braking
Severely
Reduced
Aircraft
decelerat
ion on
ground
and side
drift.
Partial
loss of
runway
position
control.
Risk of
collision
(C)
Occasion
al
(VI)
Catastrop
hic (this is
the worst
case)
(1) Flight
Compute
r and
Maintena
nce
Compute
r will
indicate
"Left
Main
Brake,
Pressure
Low"
Built-In
Test
interval is
1 minute
Unaccept
able
Check
Dorman
cy
Period
and
probabili
ty of
failure
Require
redundan
t
independ
ent brake
hydraulic
channels
and/or
Require
redundan
t sealing
and
Classify
O-ring as
Critical
Part Class
1
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Implementation
• PDCA or Deming cycle
• Encourages transparency
– Create baseline for more science-based decisions
• Facilitates communication
– Matrix team approach
– An aid to convince the stakeholders with trust
• Encourages a preventive approach
– Proactive control of risks and uncertainty
– Benefit of knowledge transfer by team approach
• Changes behavior
– Better understanding of risk-based decisions
– Acceptance of residual risks
Benefits of Risk Management Implementation:
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Conclusion
• Quality risk management is a process that
supports science-based and practical decisions
when integrated into quality systems.
• Effective quality risk management can facilitate
better and more informed decisions, and can
provide regulators with greater assurance of a
company’s ability to deal with potential risks.
• In addition, quality risk management can
facilitate better use of resources by all parties.
• Quality risk management should be integrated
into existing operations and documented
appropriately.
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References and Further Readings
• ICH Q9: Quality Risk Management
• ICH Q10: Pharmaceutical Quality System
• ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
• US FDA Guidance for Industry: Q9 Quality Risk Management
• WHO GUIDELINE ON QUALITY RISK MANAGEMENT
• ISO 31000:2009, Risk management – Principles and guidelines
• ISO Guide 73:2009 Risk management – Vocabulary
• ISO 14971:2007 Medical devices -- Application of risk
management to medical devices
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“A ship is always safe at the shore
but that is NOT what it is built for.”
Albert Einstein
Editor's Notes
5 September, 2015
A perceptible and tactile Example of pharmaceutical Cross-contamination or Mix-ups.
The weakest ring in the chain is no longer a problem
Hazards exist and are inevitable.
Hazard may cause harm
Hazard may not cause harm
This is uncertainty
Risk management is to: Hazards less probably cause harm
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).