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II. 1 Quality risk management as part of…

II. 1 Quality risk management as part of…. Integrated Quality Management. Industry. Competent Authorities. Quality risk management as part of…. II.1: Integrated quality management Documentation Training and education Quality defects Auditing / Inspection Periodic review

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II. 1 Quality risk management as part of…

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  1. II. 1 Quality risk management as part of… Integrated Quality Management Industry Competent Authorities

  2. Quality risk management as part of… II.1: Integrated quality management • Documentation • Training and education • Quality defects • Auditing / Inspection • Periodic review • Change management / change control • Continual improvement

  3. II.1: QRM as Part of integrated Quality Management • Documentation • To review current interpretations and application of regulatory expectations • To determine the desirability of and/or developthe content for SOPs, guidelines, etc. ICH Q9

  4. Law, regulations, requirements Existing internal Where documentation to be in system future? (Mission, Policy) What to do? (e.g. Directives) How to do? (e.g. Guidelines) Detailed instructions Records (e.g. Standard Operating Procedures) Records & Rules & Procedures (internal regulations) Reports Existing document structure

  5. Include ICH Q9 Risk-based approach Consider ICH Q9 Implementrisk-based thinking e.g. FMEA tablelist of residual risks Examples for using specific tools

  6. EXAMPLE Application of documentation system • A topic for any quality management system might be a“risk-based approach” for decision making • Include consideration of ICH Q9 guideline in the “directive on Quality Unit-activities” as a requirement • During periodic review of regulations, policies, guidelines and standard operating procedures (SOP) etc. think about implementing the ICH Q9 principles • Share examples of specific tools and their useas a means of sharing best practice

  7. II.1: QRM as Part of integrated Quality Management • Training and education • To determine the appropriateness of initial and/or ongoing training sessions • Based on education, experience and working habits • A periodic assessment of previous training (effectiveness) • To identify the training, experience, qualifications and physical abilities • To perform an operation reliably and with no adverse impact on the quality of the product ICH Q9

  8. II.1: QRM as Part of integrated Quality Management • Quality defects • To provide the basis for identifying, evaluating, and communicating the potential quality impact of a suspected quality defect, complaint, trend, deviation, investigation, out of specification result, etc. • To facilitate risk communications • To determine appropriate action to address significant product defects, in conjunction with regulatory authorities (e.g., recall) ICH Q9

  9. EXAMPLE Assess the history of known quality defects • Vision • Robust Processes, non-recurrent Q-problems • Target • Continuous improvement to resolve known problemse.g. from CAPA, inspections/audits, non robust processes • Preventatively work towards the achievement of a high reliability, productivity, quality of all that we do • Manage dedicated projects to support site / departments / process / products

  10. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R i n s o k i t a M Risk Control c a i n n a u g m Risk Reduction e m m o e C n t k t Risk Acceptance s o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Assess the history of known quality defects ICH Q9 Site approach Identification of opportunities for improvement Use risk assessment tool -risk analysis -risk evaluation & prioritization Select improvement opportunities Dedicated projects - Establish a team Problem solving approach Risk review : re-application of risk assessment tool

  11. EXAMPLE Assess the history of known quality defects • Approach • Increase the knowledge of weaknesses for all processesat the site and evaluate the related risks • Tackle individual issues by problem solving methods e.g. root cause analysis, statistics, tools • Tool • Risk Assessment tools: select dynamic tool to identify which are the most significant problems in order toallow identification of priorities (e.g. FTA, FMEA, etc.) • SixSigma type Project approach for problem solvingteams on each identified priority

  12. EXAMPLE Assess the history of known quality defects The project approach • Teamwork (inter-departmental teams) possibly using a facilitator • Select methodology • Commit resources appropriate to the project, priority and size • Problem solving structure • Problem Finding & Setting • Problem Analysis • Problem solution identification • Sharing with management (communication) • Decision making & implementation

  13. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events II.1: QRM as Part of integrated Quality Management Deviation / Investigation Report • The event triggers a review of quality risk management decisions • to control or accept risk related to a process • to ensure these decisions are still valid based on the new learning • In detail this could include: • Initiate Quality Risk Management process: Product and process information • Define the problem: Detailed description of the discrepancy

  14. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Deviation/ Investigation Report • Risk assessment: Risk analysis • Assessment of effects of the discrepancy Examples if applicable: • Product quality • Drug safety • Registration files / Marketing authorisation • Systems in place • Availability of goods: potentially insufficient stock levels • Identification of the root cause

  15. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Deviation/ Investigation Report • Risk assessment: Risk evaluation • Consequences for other products / batches • Systems failure • Evaluation of • Performed • Foreseen actions • Measurements • …

  16. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Deviation/ Investigation Report • Risk Control: Risk Reduction/ Mitigation • Corrective actions to resolve the discrepancy • Corrective actions to avoid a recurrence in the future • Risk Control: Risk Acceptance • Conclusions of measures taken • Decisions on disposition of the material • Define Follow up actions (if applicable) • Management summary (if applicable) • Date and signature • responsible manager • approval of QU

  17. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Deviation/ Investigation Report • Risk Communication • Frequent interactions (e.g. short daily meeting) • Informal meetings • Scheduled regular meetings (minutes)

  18. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Deviation/ Investigation Report • Risk Review • Follow up of action items • Summary and evaluation e.g. Annual Product Review

  19. EXAMPLE One page:Deviation/ Investigation Report

  20. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Complaint/ Issue Management • Initiate Quality Risk Management process • Information on the complaint/ issue • Product information • Risk identification: Define the problem • Detailed description of the complaint/ issue • Risk to patient? Recall needed? • Risk communication: to central coordination unit

  21. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Complaint/ Issue Management • Risk assessment: Risk analysis • Assessment of effects of the discrepancy Examples if applicable: • Lot tracing • Product quality • Patient impact • Registration/ Marketing authorisation • Systems in place • Availability of stock: potentially insufficient stock levels.. • Identification of the root cause • Risk communication: to expert team

  22. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Complaint/ Issue Management Risk assessment: Risk evaluation • Consequences for other batches/ products • Systems failure • Evaluation of • Available data • Performed actions • Foreseen actions • Measurements • … • Risk communication: to central coordination unit; involve management, if appropriate

  23. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Complaint/ Issue Management • Risk Control: Risk Reduction/ Mitigation • Corrective actions to resolve the discrepancy • Corrective actions to avoid a recurrence in the future • Risk Control: Risk Acceptance • Conclusions of measures taken (management sign off) • Decisions on disposition of the material • Define follow up actions (if applicable) • Management summary (if applicable) • Date and signature of minutes • Risk communication: management to decide “next steps”

  24. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Complaint/ Issue Management • Output/ result: Risk Communication Internal • Sites / Affiliates • Informal meetings • Address in regular meetings • Training sessions External • Communicate with Competent Authorities (e.g. Field Alert, incident summary) • “To whom it may concern” – letters • Pharmacies

  25. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R n i s o i k t a M c Risk Control i a n n u a g m Risk Reduction e m m o e C n t k t s Risk Acceptance o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Complaint/ Issue Management • Risk Review • Follow up of action items • Summary and evaluation e.g. Product Quality Review, Annual Product Review, follow-up report

  26. II.1: QRM as Part of integrated Quality Management • Auditing / Inspection • To define the frequency and scope of audits • Taking into account factors such as: • Existing legal requirements • Overall compliance status and history of the company • Robustness of a company’s quality risk management activities • Complexity of the site, manufacturing process, product and its therapeutic significance • Compliance status and history • Results of previous audits/inspections • Number and significance of quality defects (e.g, recall) • Results of previous audits/inspections • Majorchanges of building, equipment, processes, key personnel • Experience with manufacturing of a product (e.g. frequency, volume, number of batches) • Test results of official control laboratories ICH Q9

  27. EXAMPLE Risk Control Risk Assessment Data sources include Quality Systems (“Q10”) & Mfrg Science (Q8) Inspections Risk Communication & Risk Review Start cGMP/Compliance Inspections Risk Identification(Databases) Risk Acceptance (Work Planning) Risk Analysis & Risk Evaluation(Multi-Factorial Risk Model) Risk Reduction(Risk Ranking and Filtering) D.Horowitz, FDA April 2005

  28. EXAMPLE Scheduling audits: A framework How industry might be able to set up a risk-based evaluation scheme to assess the need to audit. A similar approach could be used by competent authorities (CA) for scheduling inspections. 1. Brainstorm to create a list of manufacturers / traders to be audited 2. Evaluate all sources of audit reports from competent authorities, competent companies or third parties conducted according local and/or other GMP-standards (e.g. PIC/S, WHO respective VFA, APIC) S. Rönninger & EFPIA TG foreign inspections Feb.06

  29. EXAMPLE Scheduling audits: A framework 3. Evaluate risk factor according to criteria based on managing risk for patients, which can (easily) be evaluated and maintained: • Severity: Compliance: effects safety & efficacy • Severity: Patient interest: effects availability • Probability: Complexity: Drug(medicinal)product, API etc. • Detectability: Audit History frequency of audit/inspections S. Rönninger & EFPIA TG foreign inspections Feb.06

  30. EXAMPLE Scheduling audits: A framework 4. Weighting on to protection of patient See list on following slides:- In case of different activities take the highest ranking!- In case their is nothing known, take the highest ranking! S. Rönninger & EFPIA TG foreign inspections Feb.06

  31. EXAMPLE Scheduling audits: A framework • Compliance (Severity)patient risk: addressing safety & efficacy S. Rönninger & EFPIA TG foreign inspections Feb.06

  32. EXAMPLE Scheduling audits: A framework • Compliance (Severity)patient risk: addressing availability S. Rönninger & EFPIA TG foreign inspections Feb.06

  33. EXAMPLE Scheduling audits: A framework • Complexity (Probability) S. Rönninger & EFPIA TG foreign inspections Feb.06

  34. EXAMPLE Scheduling audits: A framework • History (Detectability) S. Rönninger & EFPIA TG foreign inspections Feb.06

  35. EXAMPLE Scheduling audits: A framework 5. Multiply the factors 6. Sort by overall risk factor 7. Announce audits on a predetermined figure e.g. 96 S. Rönninger & EFPIA TG foreign inspections Feb.06

  36. EXAMPLE Scheduling audits: A framework Why “96”? Conclude to schedule an audit when, • Compliance/Severity: Safety & Efficacy = medium (3) or more • Compliance/Severity: Availability       = major (4) or more • Complexity: Probability                       = indirect use for patient (2) or more • History: Detectability                           = 3 years ago (4) or more This would result in 3 x 4 x 2 x 4 = 96 EFPIA TG foreign inspections Feb.06

  37. EXAMPLE Scheduling audits • Result: an overview • Updating once a year for planning Weighted factors Indication for priority Do not trust in the values only

  38. II.1: QRM as Part of integrated Quality Management • Periodic review • To select, evaluate and interpret trendresults within the product quality review • To interpret monitoring datae.g. to support an assessment of the need for revalidation, changes in sampling etc. ICH Q9

  39. II.1: QRM as Part of integrated Quality Management • Change management / change control • To manage changes based on knowledge and informationaccumulated in pharmaceutical development and during manufacturing • To evaluate the impactof the changes on the availability of the final product • To evaluate the impact on product quality of changes • To determine appropriate actions preceding the implementation of a change ICH Q9

  40. EXAMPLE Initiate Quality Risk Management Process Risk Assessment Risk Identification d e s u c o f Risk Analysis m a e T Risk Evaluation unacceptable R i n s o k i t a M Risk Control c n a i o n n i t a u a t g l m Risk Reduction u e s m m n o o e c C n l t a k t n Risk Acceptance s r o i e o t R n l I s t n Output / Result of the e m Quality Risk Management Process e v l o v n i r Risk Review e d l o h Review Events e k a t S Responsibilities in case of Change Control Industry Regulators

  41. II.1: QRM as Part of integrated Quality Management • Continual improvement • To facilitate continual improvement in processes throughout the product lifecycle ICH Q9

  42. EXAMPLE Customer Requirement Complaint etc. Change Control, Annual Review Pharmaceutical Development Regulatory Submission Supplement/ Variation Define Quality Risk Management Manufacture Technology Transfer Customer Satisfaction Design Continual Improvement All red arrows are a part of Risk Communication Takayoshi Matsumura, Eisai Co.

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