Quality Management Systems in different industries - from ISO 9001 to cGxP

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This presentation is about the design and implementation of Quality Management Systems (QMS) in different industries.

In this presentation you will learn more about the history and development of quality management systems (QMS),
the importance and benefits of a QMS for various industries,
quality principles and Good Manufacturing Practices (GMP) in life sciences, the most important requirements of an ISO 9001 QMS,
the most important requirements of GMP regulations and how to develop and implement a QMS for various industries.

The speakers, Luc Marivoet and Luc Huybreghts, both work in very different industries. They both talked about quality management systems from their own experience and very different and interesting angles.

This presentation is ideal for all professionals who want to include quality management in their projects and daily activities and who want to take the overall quality level of their organization to the next level.

Do you have any questions regarding quality management or the implementation of a QMS for your organization? Don't hesitate and visit our website at www.pauwelsconsulting.com

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  • A consume – patient – cannot detect (smell ,touch, or sight) that a drug is safe of if it will work.
    Testing alone is not adequate enough to ensure quality. Testing is only done on a small sample of a batch.
  • A vacancy for a large life-science company
    Different terms associated with QMS
    GxP requirements & ISO standards
    Improvement & review
  • A vacancy for a large life-science company
    Different terms associated with QMS
    GxP requirements & ISO standards
    Improvement & review
  • Hier heb ik een overzicht van de verschillende GDP’s op een tijdslijn bij elkaar gebracht.
    94: EU GDP: heel algemeen – weinig specifieke details – voornamelijk gericht op cold chain
    2001: US FDA
    2006: USP 1079/ WHO/
    2007: PDA report 39/ IATA chapter 17
    Local regulations
    2010: PDA report 46 Last mile – to end user
    2011: WHO update – Saoudi Arabia
    2012: EU GDP revised.

  • Flexible: modern quality systems and risk management approaches implemented on top
  • PDA: Parenteral Drug Association
    ISPE: International Society for Pharmaceutical Engineers
    IATA: International Air Transport Association
    C-TPAT: customs trade partnership (against terrorism)
    TAPA: transported asset protection association
    Known Consignor regualtion (2010/May 2013): improved security of the supply chain
  • PIC/S: lead the international development, implementation and maintenance of GMP standards and QS in the field of medicinal products
  • PIC/S: lead the international development, implementation and maintenance of GMP standards and QS in the field of medicinal products
  • Comprehensive quality systems model
    Fit in with the requiremetns of cGMP regulations – bridge with current understanding
    Not intended to create new requirements
    Major sections: ISO related – management responsibilities, resources, reveiw and evaluation
  • Quality Management Systems in different industries - from ISO 9001 to cGxP

    1. 1. Quality Management Systems (QMS) Luc Marivoet & Luc Huybreghts Antwerp, March 30 , 2017
    2. 2. 22 0 Presented by Luc Marivoet, Senior Consultant QM / Engineering Services Luc Huybreghts, Senior Consultant QA & Compliance Lecturers Using Craftsmanship in QMS
    3. 3. 33 0 Goal The goal of today’s session: Guide you through the world of Quality Management Systems (QMS) • What is a QMS • Importance & benefits of a QMS • Different types of Quality Management Systems: • Process-oriented : ISO 9001 – Luc Marivoet • Product-oriented : cGxP – Luc Huybreghts • ISO 9001 and cGxP: a comparison • Conclusion
    4. 4. 44 1 A brief history of Quality How it started Handcrafting Industrial Revolution Mass production Deming, Juran and Japan Improving organizational process World War II Sampling for inspection The American Response Total Quality Management Late 20th Century Quality Management System
    5. 5. 55 What • Definition: A system by which an organization aims to reduce and eventually eliminate nonconformance to specifications, standards, and customer expectations in the most cost effective and efficient manner. Benefits • Meeting customer’s requirements • Meeting organization’s requirements 2 Quality Management Systems Different approaches • Process-oriented: ISO 9001 • Product-oriented: cGMP
    6. 6. 66 2 Quality Management Systems
    7. 7. 77 What • Most popular standard. • Agreement or best practice. • Reflects professionalism. Benefits • Consistent quality. • Meet the customer’s requirements. • Comply with the law and legislation. • Meet the organisation’s own requirements. • Streamline your business processes. • Increase customer satisfaction. 3 Quality Management System ISO 9001
    8. 8. 88 3 Quality Management System ISO 9001 Historical timeline ISO 9001:1987 Procedures ISO 9001:1994 Say what you do & do what you say ISO 9001:2000 Process Approach & PDCA ISO 9001:2008 Process Approach & PDCA ISO 9001:2015 Context Risk / Opportunity
    9. 9. 99 Normative reference • QMS standards for which ISO 9001 is a normative reference: 3 Quality Management System ISO 9001
    10. 10. 1010 ISO 9000 series 3 Quality Management System ISO 9001 ISO 9000 Quality Management Systems – Fundamentals and vocabulary ISO 9001 Quality Management Systems – Requirements ISO/TS 9002 Quality Management Systems – Guidelines for the application of ISO 9001:2015
    11. 11. 1111 3 Quality Management System ISO 9001 Plug-in model
    12. 12. 1212 4 Quality Management Principles 1. Customer Focus 2. Leadership 3. Engagement of people 4. Process Approach 5. Improvement 6. Evidence- based Decision Making 7. Relationship Management
    13. 13. 1313 5 Key Requirements of ISO 9001
    14. 14. 1414 4. Context of the organization • Understanding the organization and its context. • Understanding the needs and expectations of interested parties. • Determining the scope of the quality management system. • Quality management system and its processes. 5 Key Requirements of ISO 9001
    15. 15. 1515 4. Context of the organization • Understanding the organization and its context. 5 Key Requirements of ISO 9001 POLITICALTECHNOLOGYMARKET RESOURCESHUMANASPECTSOPERATIONAL S T R A T E G Y EXTERNAL ISSUES INTERNAL ISSUES
    16. 16. 1616 4. Context of the organization • Understanding the organization and its context. 5 Key Requirements of ISO 9001 STRENGTH WEAKNESS OPPORTUNITY THREAT InternExtern
    17. 17. 1717 4. Context of the organization • Understanding the needs and expectations of interested parties. 5 Key Requirements of ISO 9001
    18. 18. 1818 4. Context of the organization • Determining the scope of the quality management system. 5 Key Requirements of ISO 9001
    19. 19. 1919 4. Context of the organization • Quality management system and its processes. 5 Key Requirements of ISO 9001
    20. 20. 2020 4. Context of the organization • Quality management system and its processes. 5 Key Requirements of ISO 9001
    21. 21. 2121 5. Leadership • Leadership and commitment. • Policy. • Organizational roles, responsibilities and authorities. 5 Key Requirements of ISO 9001
    22. 22. 2222 5. Leadership • Leadership and commitment. • Policy. • Organizational roles, responsibilities and authorities. 5 Key Requirements of ISO 9001
    23. 23. 2323 6. Planning • Actions to address risks and opportunities. • Quality objectives and planning to achieve them. • Planning of changes. 5 Key Requirements of ISO 9001
    24. 24. 2424 6. Planning • Actions to address risks and opportunities. 5 Key Requirements of ISO 9001
    25. 25. 2525 6. Planning • Actions to address risks and opportunities. 5 Key Requirements of ISO 9001
    26. 26. 2626 6. Planning • Quality objectives and planning to achieve them. 5 Key Requirements of ISO 9001
    27. 27. 2727 6. Planning • Quality objectives and planning to achieve them. 5 Key Requirements of ISO 9001
    28. 28. 2828 6. Planning • Planning of changes. 5 Key Requirements of ISO 9001
    29. 29. 2929 7. Support • Resources. • Competence. • Awareness. • Communication. • Documented information. 5 Key Requirements of ISO 9001
    30. 30. 3030 7. Support • Resources. 5 Key Requirements of ISO 9001
    31. 31. 3131 7. Support • Competence. 5 Key Requirements of ISO 9001
    32. 32. 3232 7. Support • Competence. 5 Key Requirements of ISO 9001
    33. 33. 3333 7. Support • Awareness. 5 Key Requirements of ISO 9001
    34. 34. 3434 7. Support • Communication. 5 Key Requirements of ISO 9001
    35. 35. 3535 7. Support • Communication. 5 Key Requirements of ISO 9001
    36. 36. 3636 7. Support • Documented information. 5 Key Requirements of ISO 9001
    37. 37. 3737 7. Support • Documented information. 5 Key Requirements of ISO 9001
    38. 38. 3838 8. Operation • Operational planning and control. • Requirements for products and services. • Design and development of products and services. • Control of externally provided processes, products and services. • Production and service provision / Release of products and services. • Control of nonconforming outputs. 5 Key Requirements of ISO 9001
    39. 39. 3939 8. Operation • Operational planning and control. 5 Key Requirements of ISO 9001
    40. 40. 4040 8. Operation • Operational planning and control. 5 Key Requirements of ISO 9001
    41. 41. 4141 8. Operation • Requirements for products and services. 5 Key Requirements of ISO 9001
    42. 42. 4242 8. Operation • Requirements for products and services. 5 Key Requirements of ISO 9001
    43. 43. 4343 8. Operation • Design and development of products and services. 5 Key Requirements of ISO 9001
    44. 44. 4444 8. Operation • Design and development of products and services. 5 Key Requirements of ISO 9001
    45. 45. 4545 8. Operation • Control of externally provided processes, products and services. 5 Key Requirements of ISO 9001
    46. 46. 4646 8. Operation • Production and service provision. • Release of products and services. • Control of nonconforming outputs. 5 Key Requirements of ISO 9001
    47. 47. 4747 9. Performance evaluation • Monitoring, measurement, analysis and evaluation. • Internal audit. • Management review. 5 Key Requirements of ISO 9001
    48. 48. 4848 9. Performance evaluation • Monitoring, measurement, analysis and evaluation. 5 Key Requirements of ISO 9001
    49. 49. 4949 9. Performance evaluation • Monitoring, measurement, analysis and evaluation. 5 Key Requirements of ISO 9001
    50. 50. 5050 9. Performance evaluation • Internal audit. 5 Key Requirements of ISO 9001
    51. 51. 5151 9. Performance evaluation • Internal audit. 5 Key Requirements of ISO 9001
    52. 52. 5252 9. Performance evaluation • Management review. 5 Key Requirements of ISO 9001
    53. 53. 5353 10. Improvement • Nonconformity and corrective action. • Continual improvement. 5 Key Requirements of ISO 9001
    54. 54. 5454 10. Improvement • Nonconformity and corrective action. 5 Key Requirements of ISO 9001 NONCONFORMITY CORRECTION CORRECTIVE ACTION ACTION TO ADDRESS THE RISK
    55. 55. 5555 10. Improvement • Continual improvement. 5 Key Requirements of ISO 9001
    56. 56. 5656 QUESTIONS 6 Questions
    57. 57. 5757 What • Definition: A system by which an organization aims to reduce and eventually eliminate nonconformance to specifications, standards, and customer expectations in the most cost effective and efficient manner. Benefits • Meeting customer’s requirements • Meeting organization’s requirements RQuality Management Systems Different approaches • Process-oriented: ISO 9001 • Product-oriented: cGMP
    58. 58. 5858 RQuality Management Systems
    59. 59. 5959 Good Manufaturing Practices • What – why • Historical overview • Structure • Eudralex • FDA • Evolution – latest trends • Dangers & pittfalls • Business enabler Comparison & relation with ISO Conclusion cGMP
    60. 60. 6060 cGMP Do you trust the pill you took today ? The Matrix
    61. 61. 6161 cGMP Quality should be built into the product and testing alone cannot be relied on to ensure product quality.
    62. 62. 6262 cGMP The function holder will maintain a Pharmaceutical Quality System as defined in Article 47 of Directive 2001/83/EC and laid down in Eudralex Volume 4 GMP guidelines; in both GMP and GDP requirements and in ISO standards Responsibilities: • Review and improve the Quality Management System • Coordinate the quality system activities • Ensure that necessary KPI’s are in place • Coordinate the activities of inspection readiness and ISO certification • Definition of Quality Objectives and development of a Quality Mindset • Provide input for Quality Improvement Meetings and Quality Review Meetings
    63. 63. 6363 What • current Good Manufacturing Practices • Pharmaceutical industry – life-sciences • It is the LAW – regulatory authorities Belgium: FAGG Brazil: ANVISA EU: EMA UK: MHRA USA: FDA cGMP
    64. 64. 6464 India Israel Biologics Control Act Federal Food, Drug and Cosmetic Act Guidance Documents Chinese Milk Scandal Tylenol Thalidomide The Pure Food and Drug Act Public Health Services Act Update Eudralex Chapter 1 cGMP - timeline
    65. 65. 6565 What • minimum requirements – what to do, never how • Current: continuous improvement – use up-to-date techniques • Flexible • cGxP cGxP Finding Proof of Principle Animal Studies Clin. Phase I Clin. Phase II Clin. Phase III Market GLP GMP GCP GMP GDP
    66. 66. 6666 Why • patient protection • a response of the authorities • prevent future tragedies • processes: reliable and reproducible • quality is built into the design and manufacturing – at each step • identity, strenght, quality and purity of drug products cGMP
    67. 67. 6767 cGxP – general Combination of regulations and guidelines Regulatory Authorities: Argentina Egypt Romania Australia FDA Saudi Arabia Austria ICH Singapore ANVISA India S. Africa Canada Ireland S. Korea China Italy UAE Czech Rep. Malaysia Venezuela EU Mexico MHRA Guidance standards ICH International Conference of Harmonisation PDA Parenteral Drug Association PIC/S Pharmaceutical Inspection Convention Mandatory standards WHO – World Health Organization
    68. 68. 6868 Latest trends in cGMP: • ICH – International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use • EU – Japan – USA: harmonization • April 1990: Brussels • Q9 – Risk Assessment • Q10 – Pharmaceutical Quality Systems • Q11 – Development and manufacturing of drug substances (draft) cGMP
    69. 69. 6969 Latest trends in cGMP: • PDA – technical reports – industry practices • PIC/S : partner of WHO, Unicef, EMA – 46 countries • Facilitate to maintain mutual confidence • Exchange cGMP information and experience • www.picscheme.org cGMP
    70. 70. 7070 Structure GMP (Eudralex volume 4) • Part 1: GMP Chapters + Annexes (19 Guidelines) cGMP GMP Chapters (Part1) Annexes 1. Pharmaceutical Quality System 1. Manufacture of Sterile Products 2. Personnel 2. Manufacture of Biological active substances and Products for human use 3. Premise and Equipment 3. Manufacture of Veterinary Products 4. Documentation 6. Manufacture of Medicinal Gases 5. Production 9. Manufacture of Liquids, Creams and Ointments 6. Quality Control 11. Computerised Systems 7. Outsourced Activities 15. Qualification and Validation 8. Complaints and recall 17. Parametric Release 9. Self Inspection 19. Reference and Retention Samples
    71. 71. 7171 Structure GMP (Eudralex volume 4) • Part 1: GMP Chapters + Annexes: 1-19 (guidelines) • Part 2: Basic Requirements for Active Substances used as starting materials • Part 3 – GMP related documents o Site Master File o Q9 Quality Risk Management o Q10 Guidance on Pharmaceutical Quality System o MRA Batch Certificate cGMP
    72. 72. 7272 Structure GMP (FDA Code of Federal Regulations) US FDA Title 21 CFR Parts • Part 11 – electronic records and signatures • Part 210 – Current Good Manufacturing Practices in Manufacturing, Processing, Packaging or Holing of Drugs; General • Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals • Part 600 – Biological Products: general • Part 601 – Licensing Biologics • Part 610 – General Biological Products Standards cGMP
    73. 73. 7373 Structure GMP (FDA Code of Federal Regulations) Guidance Documents – Guidance for industry Implement modern quality systems – risk management cGMP
    74. 74. 7474 Inspection by regulatory bodies: • Regular inspections • Pre-approval inspections (PAI) • System based inspections: full ≥ 4 systems partial ≥ 2 systems • Observations: • 483 – warning letter • published cGMP
    75. 75. 7575 GxP-basic QMS model Resource • Raw materials • Packaging materials • Personnel: training & hygiene • Premises & equipment • Maintenance • Calibration • Environmental monitoring • Validation • Processing • Quality Control • Warehousing • Distribution Manufacture • Quality Management • Key Personnel • Documentation • Complaints & recall • Self inspection System Control Quality Data • Batch records • Samples • Release • Products • Patients
    76. 76. 7676 Management responsibilities PQS elements: process performance – product quality monitoring system – CAPA system – Change Control system management review system Enablers:knowledge management – quality risk management Pharmaceutical development Technology Transfer Commercial manufacturing Product discontinuation cGxP Investigational products cGMP - PQS Pharmaceutical Quality System
    77. 77. 7777 1. Management belief – commitment Sometimes we can’t follow procedures. We have a business to run. The validation results were marginal. We can improve the process later. We often see this manufacturing problem. We routinely rework and 100% inspect. That test result is barely out of spec. We know it is good product to release. • cGMP compliance is not a frustrating hurdle to get product to the market • Company culture • Daily experience with pharmaceutical quality assurance is lacking • Walk the talk cGMP - Pittfalls
    78. 78. 7878 2. Quality function is detached from operations I know this is a compliant procedure. I used it at my last company You are not following cGMP’s. You are supposed to use blue ink. I’m not going to deliver the bad news. That would kill my career. Don’t talk to me about cost. Quality doesn’t care about cost. • Quality unit – regulated by Code of Federal Regulations • Develop procedures in isolation – no integration • A partner – do not lose independence • QA professionals must have a working and process knowledge • QA professionals must have core skills, not just cGMP compliance cGMP - Pittfalls
    79. 79. 7979 3. Inadequate management review Are we ready for an inspection? Quality had better be sure we are. Backlog of overdue investigations again ? Dedicate a team to close them ASAP A repeated inspection observation? I thought we resolved that problem • Management personally responsible • State of cGMP compliance of their operation – QMS metrics • Quality Management Review • Logical PQS – not a random collection of poorly written procedures • 4 basic management questions • System owners are responsible for the metrics and present them cGMP - Pittfalls
    80. 80. 8080 4. Large scale cGMP performance improvement The CAPA implementation efforts are going nowhere. Manufacturing department says their priority is the production schedule We agreed that on-the-job-training is needed to reduce the human error rate, but we were just told to cut our training budget by 20%. We know that unavailability of clean vessels cause a bottleneck in the manufacturing schedule, but our capital request are continuously denied. • Warning letters are phrased as failures of the quality unit • Problems are often site-wide – multiple functions have to collaborate • Align support for cGMP initiatives cGMP - Pittfalls
    81. 81. 8181 cGMP an obstacle for business ? • Business enabler: • Individual dose – every day – not an average quality • Quality only happens intentionally • Quality can’t be tested into a product • Standard operating procedures • Documentation proves the work • Records – performance metrics • Review and trending anticipating organization, not a reactive one cGMP
    82. 82. 8282 Similarities • Written procedures and records • Controlled documents • Personnel properly trained • Work environment maintained • Non-conformances & complaints addressed • Corrective and preventive actions • Equipment maintained • Quarantining of product before release • Product release, analysis of products • Conformance to specifications cGMP – ISO 9001: a comparison
    83. 83. 8383 cGMP • Specific for pharma (manufacturing of medicines) • A legal requirement • Product quality focused: • safe, pure & effective • Detailed requirements: • what – not how • Narrow scope: production & QC • Quality unit ISO 9001 • Generic – for all types of organsiations • Voluntary – industry practice • Business focussed • customer satisfaction • Not as detailed as GMP requirements • Wide scope: entire organisation • Management representative Differences cGMP – ISO 9001: comparison
    84. 84. 8484 Conclusion • It is not either ISO or GMP – it can be both • GMP operations benefit from adding ISO 9001 required measurement, review and customer satisfactions programs • IOS companies benefit from GMP’s system control requirements and from the standard to demonstrate “safety, strength, quality and purity” of the product • Demonstrate Quality Oversight • Harmonization – ICH Quality Management System(s)
    85. 85. 8585 Questions? QUESTIONS
    86. 86. 8686 Further information Luc Marivoet Senior Consultant QM / Engineering Services luc.marivoet@pauwelsconsulting.com 09 – 324 70 80 Luc Huybreghts Senior Consultant QA & Compliance luc.huybreghts@pauwelsconsulting.com 09 – 324 70 80
    87. 87. Quality Management Systems (QMS) Luc Marivoet & Luc Huybreghts Antwerp, March 30 , 2017

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