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.
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
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.
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Enteral Pharmaceutical Packaging- By Kaleem PetkarKaleem Petkar
Here you will learn about all the enteral packaging types.
This slide also includes certain packaging types with illustrative examples.
You can download my slide absolutely free.
Thanks & regards
Petkar kaleem.
this presentation contains information about HACCP implementation in food industry. with example, easy to understand comment below how is this presentation
HACCP stands for Hazard Analysis Critical Control Point which is important and preliminary step used for ensuring safety of food before it reaches to consumers
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Enteral Pharmaceutical Packaging- By Kaleem PetkarKaleem Petkar
Here you will learn about all the enteral packaging types.
This slide also includes certain packaging types with illustrative examples.
You can download my slide absolutely free.
Thanks & regards
Petkar kaleem.
this presentation contains information about HACCP implementation in food industry. with example, easy to understand comment below how is this presentation
HACCP stands for Hazard Analysis Critical Control Point which is important and preliminary step used for ensuring safety of food before it reaches to consumers
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.
Food quality control in the food industry is the process of monitoring and verifying food product quality throughout the supply chain1. The ultimate goal is to verify that products meet stringent criteria for safety, taste, appearance, and other factors1. Key procedures in food quality control include2:
Product & Recipe Formulation
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
Introduction
Automation in pharmaceutical industry
Classification of industrial & laboratory automation
Advantages
Disadvantages
Process automation in tablet production
Example of material handling improvement
Processing step elimination or combination
Rotary tablet press
Tableting improvements
Questions
References
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Tray Dryer
Principle of Tray Dryer
Construction of Tray Dryer
Working of Tray Dryer
Qualification of Tray Dryer
Installation Qualification
Operational Qualification
Performance Qualification
References
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
Energy Resources
Conventional Energy Resources
Fossil fuels
Nuclear energy
Hydroelectric energy
Non-conventional Energy Resources
Wind energy
Bio-fuel
Solar energy
Tidal energy
Energy Resources
Conventional Energy Resources
Fossil fuels
Nuclear energy
Hydroelectric energy
Non-conventional Energy Resources
Wind energy
Bio-fuel
Solar energy
Tidal energy
Energy Resources
Conventional Energy Resources
Fossil fuels
Nuclear energy
Hydroelectric energy
Non-conventional Energy Resources
Wind energy
Bio-fuel
Solar energy
Tidal energy
Energy Resources
Conventional Energy Resources
Fossil fuels
Nuclear energy
Hydroelectric energy
Non-conventional Energy Resources
Wind energy
Bio-fuel
Solar energy
Tidal energy
Hydrogen fuel energy
Geothermal energy
References
Forest Resources
Importance of Forest Resources
Associated Problems of Forests
Deforestation
Causes of Deforestation
Effects of Deforestation
Timber Extraction
Effects of Timber Extraction
Mining
Effects of Mining
References
Mineral Resources
Types of Mineral Resources
Uses of Mineral Resources
Associated problems with Mineral Resources
Environmental problems due to extracting & using Mineral Resources
Water Resources
Use of Water Resources
Over-utilization of surface & ground water
Problems due to overuse of Surface & Ground water
Mineral Resources
Types of Mineral Resources
Uses of Mineral Resources
Associated problems with Mineral Resources
Environmental problems due to extracting & using Mineral Resources
Natural Resources
Renewable Resources
Non-renewable Resources
Difference between Renewable & Non-renewable Resources
Natural Resources & associated problems
Role of individual in conservation of natural resource
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
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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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.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
1. Topic:- RISK MANAGEMENT TOOLS
Subject Name :- Quality Management System
Subject Code:- MQA102T
Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi
Presented by:-
Machhi Dhruvi A.
1st sem M.Pharm.
3. INTRODUCTION [1]
Annex I: Risk Management Methods & Tools
• The purpose of this annex is to provide a general overview of & references for some
of the primary tools that might be used in quality risk management by industry &
regulators.
• It is important to note that no one tool or set of tools is applicable to every situation
in which a quality risk management procedure is used.
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4. BASIC RISK MANAGEMENT FACILITATION METHODS[1]
Some of the simple techniques that are commonly used to structure risk management
by organizing data and facilitating decision-making are:
• Flowcharts
• Check Sheets
• Process Mapping
• Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone
diagram).
4/6/2022 4
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5. 1. FAILURE MODE EFFECTS ANALYSIS (FMEA) [1][3]
• FMEA provides for an evaluation of potential failure modes for processes &
their likely effect on outcomes and/or product performance.
• It is a powerful tool for summarizing the important modes of failure, factors
causing these failures and the likely effects of these failures.
Potential Areas of Use(s) :-
• FMEA can be used to prioritize risks and monitor the effectiveness of risk
control activities.
• FMEA can be applied to equipment and facilities and might be used to
analyze a manufacturing operation and its effect on product or process.
4/6/2022 5
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6. 2.FAILURE MODE, EFFECTS & CRITICALITY
ANALYSIS (FMECA) [1][3]
• FMEA might be extended to incorporate an investigation of the degree of severity of
the consequences, their respective probabilities of occurrence, & their detectability,
thereby becoming a Failure Mode Effect and Criticality Analysis .
Potential Areas of Use(s) :-
• mostly be utilized for failures & risks associated with manufacturing processes;
however, it is not limited to this application.
• The output of an FMECA is a relative risk “score” for each failure mode, which is
used to rank the modes on a relative risk basis.
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7. 3. FAULT TREE ANALYSIS (FTA) [1][3]
• The FTA is an approach that assumes failure of the functionality of a product
or process.
• This tool evaluates system failures one at a time but can combine multiple
causes of failure by identifying causal chains.
Potential Areas of Use(s) :-
FTA can be used ;
• to establish the pathway to the root cause of the failure.
• to investigate complaints or deviations in order to fully understand their root
cause and to ensure that intended improvements will fully resolve the issue
and not lead to other issues (i.e. solve one problem yet cause a different
problem).
• It is an effective tool for evaluating how multiple factors affect a given issue.
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8. 4. HAZARD ANALYSIS & CRITICAL CONTROL POINTS
(HACCP) [1][2][3]
• HACCP is a systematic, proactive, and preventive tool for assuring
product quality, reliability, and safety .
• It is a structured approach that applies technical and scientific principles
to analyze, evaluate, prevent, and control the risk or adverse
consequence(s) of hazard(s) due to the design, development, production,
and use of products.
Potential Areas of Use(s) :-
• HACCP might be used to identify and manage risks associated with
physical, chemical and biological hazards (including microbiological
contamination).
• It is Most useful when product and process understanding is sufficiently
comprehensive to support identification of critical control points.
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9. HACCP consists of the following seven steps: [2]
(1) conduct a hazard analysis and identify preventive measures for each step of
the process;
(2) determine the critical control points;
(3) establish critical limits;
(4) establish a monitoring system to monitor the critical control points;
(5) establish the corrective action to be taken when monitoring indicates that the
critical control points are not in a state of control;
(6) establish system to verify that the HACCP system is working effectively;
(7) establish a record-keeping system.
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10. SEVEN PRINCIPLES OF HACCP [3]
7. Establish record keeping & documentation procedures
6. Establish verification procedures
5. Establish corrective actions
4. Establish monitoring procedures
3. Establish critical limits
2. Determine the critical control points (CCPs)
1. Conduct a hazard analysis
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11. Principle 1
List all potential hazards associated with each step, conduct a hazard
analysis, and consider any measures to control identified hazards
• It involves listing of the steps in the process & identify that where significant hazards
are likely to occur.
• HACCP will focus on hazards that can be prevented, eliminated or controlled.
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12. A two-stage hazard analysis is recommended.
• During the first stage, the team should review the materials, activities, equipment,
storage, distribution and intended use of the product.
• A list of the potential hazards (biological, chemical and physical) which may be
introduced, increased or controlled in each step should be drawn up.
• During the second stage, a hazard evaluation should be conducted, i.e. the severity of
the potential hazards and the probability of their occurrence should be estimated.
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13. Potential hazards in relation to at least the following should be
considered:
— materials and ingredients;
— physical characteristics and composition of the product;
— processing procedures;
— microbial limits, where applicable;
— premises;
— equipment;
— packaging;
— sanitation and hygiene;
— personnel
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14. Principle 2
Determine critical control points (CCPs)
• A CCP is a step at which control can be applied and is essential to prevent or eliminate
a pharmaceutical quality hazard or reduce it to an acceptable level.
• It is determined by the use of a decision-tree, which facilitates a logical approach. The
way that a decision-tree is used will depend on the operation concerned, e.g.
production, packing, reprocessing, storage, distribution. Training in the use of decision-
trees should be given.
• If a hazard has been identified at a step where control is necessary for safety & no
control measure exists at that step, or any other, the product or process should be
modified at that step, or at an earlier or later stage, to include such a control measure.
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15. Principle 3
Establish critical limits for each Critical Control Points (CCP)
• Critical limits must be specified and verified, if possible, for each critical control point.
• A Critical Control Limit (CCL) is a maximum or minimum value to which a biological,
chemical, physical parameters must be controlled at a Critical Control Point to prevent,
eliminate or reduce to an acceptable level.
• This criteria include measurements of temperature, time, moisture level, pH, and
sensory parameters, such as visual appearance and texture.
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16. Principle 4
Establish a monitoring system for each Critical Control Points (CCP)
• Monitoring is the scheduled measurement or observation of a CCP relative to its
critical limits.
It should describe;
- How measurements will be taken
- When measurements will be taken
- Who is responsible for the measurements taken
- How frequently the measurements are taken
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17. Principle 5
Establish corrective actions
• Specific corrective actions should be developed for each CCP in the HACCP
system in order to deal with deviations when they occur.
• These actions should ensure that the CCP is brought under control.
• It includes identification of the problem & taken to assure that the problem will not
occur again .
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18. • Corrective actions should include at least the following:
(a) determination and correction of the cause of non-compliance
(b) determination of the disposition of the non-compliant product
(c) recording of the corrective actions that have been taken
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19. Principle 6
Establish verification procedures
• Procedures should be established for verification.
• Verification and auditing of methods, procedures and tests, including random
sampling & analysis, can be used to determine whether the HACCP system is
working correctly.
• Examples of verification activities include:
— review of the HACCP system and its records
— review of deviations and product dispositions
— confirmation that CCPs are kept under control
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20. Principle 7
Establish documentation and record keeping
• Efficient & accurate documentation & record keeping are essential to the application
of a HACCP system.
• Examples of activities for which documentation is required include:
— hazard analysis
— CCP determination
— HACCP plan
— critical limit determination
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21. • Examples of activities for which records are required include:
— CCP monitoring activities
— process steps
— associated hazards
— critical limits
— verification procedures and schedule
— deviations
— associated corrective actions
— modifications to the HACCP system
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22. 5. HAZARD OPERABILITY ANALYSIS (HAZOP) [1][3]
• HAZOP is based on a theory that assumes that risk events are caused by
deviations from the design or operating intentions.
• It is a systematic brainstorming technique for identifying hazards using so-
called “guide-words”.
• “Guide-words” (e.g., No, More, Other Than, Part of, etc.) are applied to
relevant parameters (e.g., contamination, temperature) to help identify
potential deviations from normal use or design intentions.
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23. Potential Areas of Use(s):-
• applied to manufacturing processes, including outsourced production &
formulation, as well as the upstream suppliers, equipment and facilities for
drug substances & drug (medicinal) products.
• also been used primarily in the pharmaceutical industry for evaluating process
safety hazards.
• The output of a HAZOP analysis is a list of critical operations for risk
management.
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24. 6. PRELIMINARY HAZARDS ANALYSIS (PHA) [1][3]
• PHA is a tool of analysis based on applying prior experience or knowledge of a
hazard or failure to identify future hazards, hazardous situations and events that
might cause harm, as well as to estimate their probability of occurrence for a given
activity, facility, product or system.
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25. • The tool consists of:
1) the identification of the possibilities that the risk event happens,
2) the qualitative evaluation of the extent of possible injury or damage to health
that could result &
3) a relative ranking of the hazard using a combination of severity and
likelihood of occurrence, and
4) the identification of possible remedial measures.
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26. Potential Areas of Use(s)
• useful when analyzing existing systems or prioritizing hazards where
circumstances prevent a more extensive technique from being used.
• It can be used for product, process and facility design as well as to evaluate
the types of hazards for the general product type, then the product class, and
finally the specific product.
• PHA is most commonly used early in the development of a project when there
is little information on design details or operating procedures; thus, it will
often be a precursor to further studies.
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27. 7. RISK RANKING & FILTERING [1]
• Risk ranking and filtering is a tool for comparing and ranking risks.
• Risk ranking of complex systems typically requires evaluation of multiple
diverse quantitative & qualitative factors for each risk.
• The tool involves breaking down a basic risk question into as many
components as needed to capture factors involved in the risk.
Potential Areas of Use(s):-
• used to prioritize manufacturing sites for inspection/audit by regulators or
industry.
• Risk ranking is useful when management needs to evaluate both
quantitatively-assessed and qualitatively-assessed risks within the same
organizational framework.
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28. 8. SUPPORTING STATISTICAL TOOLS [1]
• Statistical tools can support and facilitate quality risk management.
• They can enable effective data assessment
• aid in determining the significance of the data set(s), &
• facilitate more reliable decision making.
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29. A listing of some of the principal statistical tools commonly used in the
pharmaceutical industry is provided:
• Control Charts,
for example:
- Acceptance Control Charts
- Control Charts with Arithmetic Average and Warning Limits
- Cumulative Sum Charts
- Shewhart Control Charts
- Weighted Moving Average
• Design of Experiments (DOE)
• Histograms
• Pareto Charts
• Process Capability Analysis
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30. QUESTIONS
1. Write a note on Risk assessment within the HACCP system. (summer 2018)
2. Write a note on Hazard Analysis & Critical Control Points. (winter 2019)
3. Enumerate different QRM tools. Describe seven steps to implement Hazard Analysis
& Critical Control Point(HACCP). (summer 2019)
4. Explain in detail Critical Control Points & Hazard Analysis. (summer 2020)
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31. REFERENCES
1. ICH Q9 guideline (pp 11-14)
2. WHO Technical Report Series No 908, 2003, Annex 7 Application of Hazard
Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals, pp
99-110
3. Mollah, Hamid, Harold Baseman, and Mike Long, eds. Risk Management
Applications in Pharmaceutical and Biopharmaceutical Manufacturing. Vol.4, John
Wiley & Sons, 2013, pp 25-33
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