SlideShare una empresa de Scribd logo
1 de 11
Quality Risk Management

          Basic
Risk Management Facilitation
         Methods
   Presentation complied by Drug Regulations – a not for
     profit organization from publicly available material
     form FDA , EDQM . WHO and similar organizations.
       Visit www.drugregulations.org for the latest in
                       Pharmaceuticals.



                                www.drugregulations.org     1
   Flowchart
   Check Sheets
   Process mapping
   Cause and Effect Diagrams (Ishikawa / fish bone)

They might be helpful to support risk identification




                                www.drugregulations.org   2
Flowcharts



     Start

    Activity
                                Pictorial
    Activity
                                 representations
                                 of a process
   Decision    No   Action

      Yes                       Breaking the process
    Result                       down into its
                                 constituent steps

                                 www.drugregulations.org   3
Check sheets




                  Present information
                   in an efficient, clear
                   format

                  May be accomplished
                   with a simple listing of
                   items


                   www.drugregulations.org    4
Process mapping

   The indicators may be selected based on unit
    operations
   Shows how they are interrelated
Potential Areas of Use(s) / outcomes
   Provides a clear and simple visual representation
    of involved steps
   Facilitates understanding, explaining and
    systematically analyzing complex processes and
    associated risks
   A pre-requisite for the use of some other tools
                                                         ICH Q9
                               www.drugregulations.org            5
Ai
       Dispensing
                                                                                     r
                    Scale                Sieving                                     Fluidized
                                                                                     Bed Dryer
                                                   Granulation        Air


   Process                                        Magnesium
                                                    Stearate
                                                                                Blendin
                                                                                g
    mapping                   Sieving




                            Tabletting
                                                                                          Packagin
                                                                                             g
                                                          Coating

                                                      www.drugregulations.org                        6
Cause and Effect Diagrams (Ishikawa / fish bone)

Environment   People    Materials


                                                          Problem
                                                         statement


   Equipment Measurement      Methods
               System

                               www.drugregulations.org          7
Cause and Effect Diagrams (Ishikawa / fish bone)

   To associate multiple possible causes with a single effect
   Constructed to identify and organize possible causes for it
   Primary branch:     represents the effect
   Major branch:       corresponds to a major cause
   Minor branch:       correspond to more detailed causal
    factors




                                       www.drugregulations.org   8
Cause and Effect Diagrams (Ishikawa / fish bone)

How to perform?
 Define and agree a precise problem statement
  (put as “head” of fish bone) Think “What could be
  its causes?” for each node
 Add it to the “fish bone” diagram
 For each line pursue back to its root cause
 Consider splitting up overcrowded sections
  “bones”
 Consider which potential root
  causes and the need for
                                            Environment     People   Materials



  further investigation on them                                                       Problem
                                                                                     statement


                                                Equipment    Measurement
                                                               System      Methods
Cause and Effect Diagrams (Ishikawa / fish bone)




                            www.drugregulations.org   10
Coating                               Drying                         Milling                Analytical
                            Temperature

  Spray Rate             Redrying

    Pan Speed                      Time        Temp
                                     Milling
    Gun Distance                                    RH                     Screen Size                    Other

       Temperature                                Air Flow                       Porosity                Sampling

Atomizing Air Pressure                          Shock Cycle                      Mill Speed                 Method
                                                                                                                             Tablet
                                                                                             Drug
                                                                                                                            Hardness
    Operator             Precompressing                               Water              Substance
   Temp/RH         Main Compressing                                 Binder                    Age
                                                                                         P.S.
 Operator            Feeder Speed                                   Temp         Process Conditions
                                                                                                LOD

                                                                                                                          Cause and
Training              Press Speed                        Spray Rate
               Punch Penetration
                                                    Spray Pattern
                                                                                     HPMC
                                                                                                                      
                                                                                                                          Effect
                        Depth
                                                                             Methoxyl
                      Tooling                                P.S.
                                                                              Hydroxyl

                                                                                                                          Diagram
   Plant              Feed                                                          P.S.
                                                 Scrape Down
  Factors            Frame                                                            LOD

                     Compressing
                                           Chopper Speed                     Other
                                                                                                                          for Tablet
                                                                                                                          Hardness
                                               Mixer Speed            Syloid
                                                                        Lactose
                                Endpoint                                                     Raw
                                                                           Coating
                                                                                            Materials
                                   Power
                                                 Granulation
                                      Time
                                                                                                www.drugregulations.org                11

Más contenido relacionado

La actualidad más candente

Product Quality Review (PQR)
Product Quality Review (PQR)Product Quality Review (PQR)
Product Quality Review (PQR)Rikul Patel
 
Ipqc 112070804017
Ipqc 112070804017Ipqc 112070804017
Ipqc 112070804017Patel Parth
 
Auditing of Granulation Operation in Dry Production Area
Auditing of Granulation Operation in Dry Production AreaAuditing of Granulation Operation in Dry Production Area
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
 
Six system inspection model
Six system inspection modelSix system inspection model
Six system inspection modelVaishali Dandge
 
Quality risk management
Quality risk managementQuality risk management
Quality risk managementpraveen dubey
 
cGMP regulations & QA function.pptx
cGMP regulations &  QA function.pptxcGMP regulations &  QA function.pptx
cGMP regulations & QA function.pptxDhruvi50
 
Packaging and Stability Requirements for Pharmaceuticals
Packaging and Stability Requirements for PharmaceuticalsPackaging and Stability Requirements for Pharmaceuticals
Packaging and Stability Requirements for PharmaceuticalsProf. Dr. Basavaraj Nanjwade
 
Pharmaceutical packaging
Pharmaceutical  packagingPharmaceutical  packaging
Pharmaceutical packagingItsShifaSheikh
 
Quality by Design and Process Analytical Technology
Quality by Design and Process Analytical TechnologyQuality by Design and Process Analytical Technology
Quality by Design and Process Analytical TechnologyMANIKANDAN V
 
Batch Review And Batch Release.pptx
Batch Review And Batch Release.pptxBatch Review And Batch Release.pptx
Batch Review And Batch Release.pptxAbhishekJadhav189260
 
Vendor Audit
Vendor Audit Vendor Audit
Vendor Audit PRAVADA
 

La actualidad más candente (20)

ICH Guidelines Q1 - Q10
ICH Guidelines Q1 - Q10ICH Guidelines Q1 - Q10
ICH Guidelines Q1 - Q10
 
Product Quality Review (PQR)
Product Quality Review (PQR)Product Quality Review (PQR)
Product Quality Review (PQR)
 
Quality risk management : Basic Content
Quality risk management : Basic ContentQuality risk management : Basic Content
Quality risk management : Basic Content
 
Granulation
GranulationGranulation
Granulation
 
Ipqc 112070804017
Ipqc 112070804017Ipqc 112070804017
Ipqc 112070804017
 
Auditing of Granulation Operation in Dry Production Area
Auditing of Granulation Operation in Dry Production AreaAuditing of Granulation Operation in Dry Production Area
Auditing of Granulation Operation in Dry Production Area
 
ICH Q9 Quality Risk Management
ICH Q9 Quality Risk ManagementICH Q9 Quality Risk Management
ICH Q9 Quality Risk Management
 
Process Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA ApproachProcess Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA Approach
 
Six system inspection model
Six system inspection modelSix system inspection model
Six system inspection model
 
Vendor Audit
Vendor AuditVendor Audit
Vendor Audit
 
Quality risk management
Quality risk managementQuality risk management
Quality risk management
 
Product quality review
Product quality reviewProduct quality review
Product quality review
 
Packaging material vendor audit
Packaging material vendor auditPackaging material vendor audit
Packaging material vendor audit
 
cGMP regulations & QA function.pptx
cGMP regulations &  QA function.pptxcGMP regulations &  QA function.pptx
cGMP regulations & QA function.pptx
 
Packaging and Stability Requirements for Pharmaceuticals
Packaging and Stability Requirements for PharmaceuticalsPackaging and Stability Requirements for Pharmaceuticals
Packaging and Stability Requirements for Pharmaceuticals
 
Pharmaceutical packaging
Pharmaceutical  packagingPharmaceutical  packaging
Pharmaceutical packaging
 
Quality by Design and Process Analytical Technology
Quality by Design and Process Analytical TechnologyQuality by Design and Process Analytical Technology
Quality by Design and Process Analytical Technology
 
Batch Review And Batch Release.pptx
Batch Review And Batch Release.pptxBatch Review And Batch Release.pptx
Batch Review And Batch Release.pptx
 
Process automation with respect to Sterile Products
Process automation with respect to Sterile ProductsProcess automation with respect to Sterile Products
Process automation with respect to Sterile Products
 
Vendor Audit
Vendor Audit Vendor Audit
Vendor Audit
 

Destacado

ICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk ManagementICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk Managementmuna_ali
 
Risk management using FMEA in pharma
Risk management using FMEA in pharmaRisk management using FMEA in pharma
Risk management using FMEA in pharmaSandeep Naik
 
Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)DEEPAK SAHOO
 
FMEA failure-mode-and-effect-analysis_Occupational safety and health
FMEA failure-mode-and-effect-analysis_Occupational safety and healthFMEA failure-mode-and-effect-analysis_Occupational safety and health
FMEA failure-mode-and-effect-analysis_Occupational safety and healthJing Jing Cheng
 
FMEA Introduction.ppt
FMEA Introduction.pptFMEA Introduction.ppt
FMEA Introduction.pptbowerj
 
Fmea presentation
Fmea presentationFmea presentation
Fmea presentationMurat Terzi
 
ICH Guideline – Q9
ICH Guideline – Q9ICH Guideline – Q9
ICH Guideline – Q9rx_sonali
 
Quality Risk Management
Quality Risk ManagementQuality Risk Management
Quality Risk ManagementDigital-360
 
Risk Analysis and Management
Risk Analysis and ManagementRisk Analysis and Management
Risk Analysis and ManagementGenie
 
FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) B...
FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) B...FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) B...
FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) B...Shivang Chaudhary
 

Destacado (20)

Quality Risk management Application of FMEA
Quality Risk management  Application of FMEAQuality Risk management  Application of FMEA
Quality Risk management Application of FMEA
 
ICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk ManagementICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk Management
 
Risk Assessment for Control of Elemental Impurities.
Risk Assessment for Control of Elemental Impurities.Risk Assessment for Control of Elemental Impurities.
Risk Assessment for Control of Elemental Impurities.
 
Risk management using FMEA in pharma
Risk management using FMEA in pharmaRisk management using FMEA in pharma
Risk management using FMEA in pharma
 
Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)
 
Who Guidance on Quality Risk Management
Who Guidance on Quality Risk ManagementWho Guidance on Quality Risk Management
Who Guidance on Quality Risk Management
 
Application of Quality Risk Management in Commissioning & Qualifcation
Application of Quality Risk Management in Commissioning & QualifcationApplication of Quality Risk Management in Commissioning & Qualifcation
Application of Quality Risk Management in Commissioning & Qualifcation
 
FMEA failure-mode-and-effect-analysis_Occupational safety and health
FMEA failure-mode-and-effect-analysis_Occupational safety and healthFMEA failure-mode-and-effect-analysis_Occupational safety and health
FMEA failure-mode-and-effect-analysis_Occupational safety and health
 
FMEA Presentation
FMEA PresentationFMEA Presentation
FMEA Presentation
 
Process fmea
Process fmea Process fmea
Process fmea
 
FMEA Introduction.ppt
FMEA Introduction.pptFMEA Introduction.ppt
FMEA Introduction.ppt
 
Introduction to Risk Management
Introduction to Risk ManagementIntroduction to Risk Management
Introduction to Risk Management
 
Fmea presentation
Fmea presentationFmea presentation
Fmea presentation
 
Quality risk management
Quality risk managementQuality risk management
Quality risk management
 
Fmea
FmeaFmea
Fmea
 
ICH Guideline – Q9
ICH Guideline – Q9ICH Guideline – Q9
ICH Guideline – Q9
 
Application of Q R M in Manufacturing Operations
Application of Q R M in Manufacturing Operations Application of Q R M in Manufacturing Operations
Application of Q R M in Manufacturing Operations
 
Quality Risk Management
Quality Risk ManagementQuality Risk Management
Quality Risk Management
 
Risk Analysis and Management
Risk Analysis and ManagementRisk Analysis and Management
Risk Analysis and Management
 
FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) B...
FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) B...FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) B...
FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) B...
 

Más de GMP EDUCATION : Not for Profit Organization

Más de GMP EDUCATION : Not for Profit Organization (20)

Pharmaceutical Quality System
Pharmaceutical Quality System Pharmaceutical Quality System
Pharmaceutical Quality System
 
New WHO Guidance on Analytical Method Validation
New WHO Guidance on Analytical Method ValidationNew WHO Guidance on Analytical Method Validation
New WHO Guidance on Analytical Method Validation
 
Blend and Content Uniformity : Industry Recommendations for Way Forward
Blend and Content Uniformity : Industry Recommendations for Way ForwardBlend and Content Uniformity : Industry Recommendations for Way Forward
Blend and Content Uniformity : Industry Recommendations for Way Forward
 
Content Uniformity and Blend Uniformity : Why FDA Withdrew the 2002 Guidance
Content Uniformity and Blend Uniformity : Why FDA Withdrew the 2002 Guidance Content Uniformity and Blend Uniformity : Why FDA Withdrew the 2002 Guidance
Content Uniformity and Blend Uniformity : Why FDA Withdrew the 2002 Guidance
 
WHO Guidance on Preparation of Laboratory Information File
WHO  Guidance on Preparation of Laboratory Information FileWHO  Guidance on Preparation of Laboratory Information File
WHO Guidance on Preparation of Laboratory Information File
 
US FDA Quality Metrics Technical Conformance Guide
US FDA  Quality Metrics Technical  Conformance GuideUS FDA  Quality Metrics Technical  Conformance Guide
US FDA Quality Metrics Technical Conformance Guide
 
Calculation of Risk Priority Numbar
Calculation of  Risk Priority NumbarCalculation of  Risk Priority Numbar
Calculation of Risk Priority Numbar
 
New PICS Guidance on Data Integrity and Management.
New PICS Guidance on Data Integrity and Management.New PICS Guidance on Data Integrity and Management.
New PICS Guidance on Data Integrity and Management.
 
New WHO Guidance on CS Validation
New WHO Guidance on CS ValidationNew WHO Guidance on CS Validation
New WHO Guidance on CS Validation
 
New WHO Guidance on Process Validation
New WHO Guidance on Process ValidationNew WHO Guidance on Process Validation
New WHO Guidance on Process Validation
 
ASTM Standard E 2500 for Commissioning and Qualifications
ASTM Standard E 2500 for Commissioning and QualificationsASTM Standard E 2500 for Commissioning and Qualifications
ASTM Standard E 2500 for Commissioning and Qualifications
 
US FDA - EU Process Validation : Determination of Number of PPQ Batches
US FDA - EU Process Validation : Determination of Number of PPQ BatchesUS FDA - EU Process Validation : Determination of Number of PPQ Batches
US FDA - EU Process Validation : Determination of Number of PPQ Batches
 
Presentation on US FDA Data Integrity Guidance.
Presentation on US FDA  Data Integrity Guidance.Presentation on US FDA  Data Integrity Guidance.
Presentation on US FDA Data Integrity Guidance.
 
Quality Risk Assessmsnt for Environmental Monitoring
Quality Risk Assessmsnt for Environmental MonitoringQuality Risk Assessmsnt for Environmental Monitoring
Quality Risk Assessmsnt for Environmental Monitoring
 
Understanding and Preventing Clean Room Contamination
Understanding and Preventing Clean Room ContaminationUnderstanding and Preventing Clean Room Contamination
Understanding and Preventing Clean Room Contamination
 
Process Validation of Legacy Products
Process Validation of Legacy ProductsProcess Validation of Legacy Products
Process Validation of Legacy Products
 
WHO Guidance on Technology Transfers
WHO Guidance on Technology TransfersWHO Guidance on Technology Transfers
WHO Guidance on Technology Transfers
 
Who Guidelines for Preparing SMF
Who Guidelines for Preparing  SMFWho Guidelines for Preparing  SMF
Who Guidelines for Preparing SMF
 
Validation of Microbiological Methods
Validation of Microbiological MethodsValidation of Microbiological Methods
Validation of Microbiological Methods
 
Presentation on EU GMP Annex 16 - Certification by QP
Presentation on EU GMP Annex 16 - Certification by QPPresentation on EU GMP Annex 16 - Certification by QP
Presentation on EU GMP Annex 16 - Certification by QP
 

Último

High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)kishan singh tomar
 
Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Vaikunthan Rajaratnam
 
Neurological history taking (2024) .
Neurological  history  taking  (2024)  .Neurological  history  taking  (2024)  .
Neurological history taking (2024) .Mohamed Rizk Khodair
 
Arthroscopic Surgery in Indore : A Minimally Invasive Guide to Joint Health
Arthroscopic Surgery in Indore : A Minimally Invasive Guide to Joint HealthArthroscopic Surgery in Indore : A Minimally Invasive Guide to Joint Health
Arthroscopic Surgery in Indore : A Minimally Invasive Guide to Joint HealthGokuldas Hospital
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentsaileshpanda05
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondSujoy Dasgupta
 
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdfSGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdfHongBiThi1
 
Forensic Nursing powerpoint presentation
Forensic Nursing powerpoint presentationForensic Nursing powerpoint presentation
Forensic Nursing powerpoint presentationKavitha Krishnan
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptPradnya Wadekar
 
AI in Action: Elevating Patient Insights
AI in Action: Elevating Patient InsightsAI in Action: Elevating Patient Insights
AI in Action: Elevating Patient InsightsEmily Kunka, MS, CCRP
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE Mamatha Lakka
 
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaMale Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaSujoy Dasgupta
 
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.aarjukhadka22
 
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfPAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfDolisha Warbi
 
blood bank management system project report
blood bank management system project reportblood bank management system project report
blood bank management system project reportNARMADAPETROLEUMGAS
 
Understanding AIDS:a roadmap to well ess
Understanding AIDS:a roadmap to well essUnderstanding AIDS:a roadmap to well ess
Understanding AIDS:a roadmap to well essAbhishekKumar524514
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationMedicoseAcademics
 

Último (20)

High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)
 
Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.
 
Neurological history taking (2024) .
Neurological  history  taking  (2024)  .Neurological  history  taking  (2024)  .
Neurological history taking (2024) .
 
Arthroscopic Surgery in Indore : A Minimally Invasive Guide to Joint Health
Arthroscopic Surgery in Indore : A Minimally Invasive Guide to Joint HealthArthroscopic Surgery in Indore : A Minimally Invasive Guide to Joint Health
Arthroscopic Surgery in Indore : A Minimally Invasive Guide to Joint Health
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing student
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and Beyond
 
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdfSGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
 
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
 
Forensic Nursing powerpoint presentation
Forensic Nursing powerpoint presentationForensic Nursing powerpoint presentation
Forensic Nursing powerpoint presentation
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.ppt
 
AI in Action: Elevating Patient Insights
AI in Action: Elevating Patient InsightsAI in Action: Elevating Patient Insights
AI in Action: Elevating Patient Insights
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE
 
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaMale Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
 
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
 
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfPAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
 
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
 
blood bank management system project report
blood bank management system project reportblood bank management system project report
blood bank management system project report
 
Understanding AIDS:a roadmap to well ess
Understanding AIDS:a roadmap to well essUnderstanding AIDS:a roadmap to well ess
Understanding AIDS:a roadmap to well ess
 
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
 

Quality risk managment basic facilitation methods

  • 1. Quality Risk Management Basic Risk Management Facilitation Methods Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EDQM . WHO and similar organizations. Visit www.drugregulations.org for the latest in Pharmaceuticals. www.drugregulations.org 1
  • 2. Flowchart  Check Sheets  Process mapping  Cause and Effect Diagrams (Ishikawa / fish bone) They might be helpful to support risk identification www.drugregulations.org 2
  • 3. Flowcharts Start Activity  Pictorial Activity representations of a process Decision No Action Yes  Breaking the process Result down into its constituent steps www.drugregulations.org 3
  • 4. Check sheets  Present information in an efficient, clear format  May be accomplished with a simple listing of items www.drugregulations.org 4
  • 5. Process mapping  The indicators may be selected based on unit operations  Shows how they are interrelated Potential Areas of Use(s) / outcomes  Provides a clear and simple visual representation of involved steps  Facilitates understanding, explaining and systematically analyzing complex processes and associated risks  A pre-requisite for the use of some other tools ICH Q9 www.drugregulations.org 5
  • 6. Ai Dispensing r Scale Sieving Fluidized Bed Dryer Granulation Air  Process Magnesium Stearate Blendin g mapping Sieving Tabletting Packagin g Coating www.drugregulations.org 6
  • 7. Cause and Effect Diagrams (Ishikawa / fish bone) Environment People Materials Problem statement Equipment Measurement Methods System www.drugregulations.org 7
  • 8. Cause and Effect Diagrams (Ishikawa / fish bone)  To associate multiple possible causes with a single effect  Constructed to identify and organize possible causes for it  Primary branch: represents the effect  Major branch: corresponds to a major cause  Minor branch: correspond to more detailed causal factors www.drugregulations.org 8
  • 9. Cause and Effect Diagrams (Ishikawa / fish bone) How to perform?  Define and agree a precise problem statement (put as “head” of fish bone) Think “What could be its causes?” for each node  Add it to the “fish bone” diagram  For each line pursue back to its root cause  Consider splitting up overcrowded sections “bones”  Consider which potential root causes and the need for Environment People Materials further investigation on them Problem statement Equipment Measurement System Methods
  • 10. Cause and Effect Diagrams (Ishikawa / fish bone) www.drugregulations.org 10
  • 11. Coating Drying Milling Analytical Temperature Spray Rate Redrying Pan Speed Time Temp Milling Gun Distance RH Screen Size Other Temperature Air Flow Porosity Sampling Atomizing Air Pressure Shock Cycle Mill Speed Method Tablet Drug Hardness Operator Precompressing Water Substance Temp/RH Main Compressing Binder Age P.S. Operator Feeder Speed Temp Process Conditions LOD Cause and Training Press Speed Spray Rate Punch Penetration Spray Pattern HPMC  Effect Depth Methoxyl Tooling P.S. Hydroxyl Diagram Plant Feed P.S. Scrape Down Factors Frame LOD Compressing Chopper Speed Other for Tablet Hardness Mixer Speed Syloid Lactose Endpoint Raw Coating Materials Power Granulation Time www.drugregulations.org 11