Quality Risk Management (ICHQ9). Understanding and Implimentation pptx

Quality risk management (QRM) is a systematic approach to assessing, controlling, communicating, and reviewing risks to the quality of the drug product across its lifecycle. The goal is to ensure product quality and patient safety by identifying potential risks, evaluating their impact, and implementing measures to mitigate or eliminate them.

QRM is a critical part of the pharmaceutical industry because product quality can directly impact patient health and safety.

1. Quality Risk Management (ICH Q9) Understanding & Implementation Dr. Ravi Kinhikar Quality Practitioner, Trainer, Certified QMS Auditor

2. What Is Quality Risk Management? Quality risk management (QRM) is a systematic approach to assessing, controlling, communicating, and reviewing risks to the quality of the drug product across its lifecycle. The goal is to ensure product quality and patient safety by identifying potential risks, evaluating their impact, and implementing measures to mitigate or eliminate them. QRM is a critical part of the pharmaceutical industry because product quality can directly impact patient health and safety. Quality risk management (QRM) Implies to entire product life cycle. Drug disco very and development Pre-cl inical research Clinical trials (Phase I, II, III) Regulatory submission, review and approval Product commercialization /scale up Post approval changes and life cycle management Product maturity End of life

3. Scope This presentation will explore Quality Risk Management for Product commercialization/scale up, post approval changes and life cycle management at manufacturing site. Pharmaceutical product manufacturing involves a series of well-defined, controlled, and validated processes designed to ensure that the final product meets the necessary quality, safety, and efficacy standards. The risk to quality is associated with criticality of each manufacturing operations and processes. Some of key processes are, Raw material procurement Raw material testing and Quality control Product development (Process, CPP, CQA, Specifications, test procedures) Forced degradation study, control of impurities Pilot scale batches (Resources, process performance and consistency) Process scale-up and Product commercialization Equipment cleaning Quality Assurance (Testing and Release, Changes, deviations, complaint etc.) Packing, Storage, logistics etc. Shelf life study Documentation and records maintenance And many more……..

4. What is a Risk? Risk: Risk is effect of uncertainty on objective . Effect: An effect is a deviation from the expected. It can be positive negative or both, and can address, create or result in opportunities and threats. Objective: Objectives can have different aspects and categories , and can be applied at different levels. Aspects and category An aspect is a activities, products, or services that can interact with processes, category is an individual who is impacted. Note: Risk is combination of probability (likelihood) and consequences and it can be one or combination of two or more.

5. Key Components of QRM Risk Assessment : Identification : Determining what could go wrong, identifying hazards, and considering possible consequences. Analysis : Understanding the nature of risk and the probability of occurrence and potential impact. Evaluation : Comparing the risk against established criteria to determine its significance . Risk Control : Reduction : Implementing measures to reduce the risk to an acceptable level. Acceptance : Acknowledging that some risk may remain and ensuring it is within acceptable limits. Risk Communication : Sharing information about risk and risk management between stakeholders, including regulators, company personnel, suppliers and customers. Risk Review : Regularly reviewing risks and the effectiveness of risk control measures throughout the product lifecycle, especially when new information becomes available or when changes occur.

6. Process Flow Diagram -QRM

7. Principles Of Quality Risk Management Risk base approach: A way to identify, assess, and manage risks, and then take action based on the level of risk. Science-Based Decision Making: Decisions should be based on scientific knowledge and the practical understanding of the product and process. Business protection: Assess, identify and control risks proactively before they cause problems to the business. Patient Protection: The primary focus is to ensure that risks to patient safety are minimized. Proportionality: The level of effort, formality, and documentation should be proportional to the level of risk. It’s a process — not a project — and orgnization may have external requirements about how often they need to review each level of risk. It is not a ‘one-and-done’ process, but an ever-evolving one.

8. Methodology – To identify the risk a) Basic risk management facilitation methods 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 (Ishikawa diagram/ fish bone diagram). P Flow chart Fishbone diagram Process Mapping Check Sheets

9. Methodology – To identify the risk b) Failure Mode Effects Analysis (FMEA) FMEA helps prioritize risks and monitor the effectiveness of risk controls. It can be applied to equipment, facilities, and manufacturing operations to identify vulnerabilities. The results of FMEA serve as a foundation for design improvements, further analysis, or resource allocation. P

10. Methodology – To identify the risk c) Failure Mode, Effects and Criticality Analysis (FMECA) FMECA in the pharmaceutical industry is primarily used to address failures and risks in manufacturing processes, though its applications extend beyond this. The output is a relative risk score for each failure mode, allowing for risk-based prioritization.

11. Methodology – To identify the risk d) Fault Tree Analysis (FTA) Fault Tree Analysis (FTA) helps trace the root cause of failures and investigate complaints or deviations to ensure improvements address issues without creating new ones. This tool evaluates how various factors influence a problem and provides a visual representation of failure modes, making it valuable for risk assessment and monitoring program development.

12. Methodology – To identify the risk e) Hazard Analysis and Critical Control Points (HACCP) HACCP helps identify and manage physical, chemical, and biological hazards, including microbiological contamination. It is most effective when there is a thorough understanding of the product and process to pinpoint critical control points. The analysis provides risk management information that aids in monitoring critical points throughout the manufacturing process and other life cycle phases. HACCP consists of the following seven steps:

13. Methodology – To identify the risk f) Hazard Operability Analysis (HAZOP) HAZOP is used in the pharmaceutical industry to evaluate process safety hazards across manufacturing processes, including outsourced production, formulation, and upstream suppliers, as well as equipment and facilities for drug substances and medicinal products. Similar to HACCP, HAZOP analysis produces a list of critical operations for risk management, facilitating regular monitoring of key points in the manufacturing process .

14. Methodology – To identify the risk g) Preliminary Hazard Analysis (PHA) PHA is useful for analyzing existing systems or prioritizing hazards, especially when more extensive techniques are not feasible . It applies to product, process, and facility design, assessing hazards progressively from the general product type to the product class and finally the specific product. Commonly conducted early in project development when design details and procedures are limited, PHA serves as a precursor to more detailed studies. Hazards identified in a PHA are typically further evaluated using additional risk management tools.

15. Establishing likelihood and consequences matrix Failure Mode Risk matrices is establish with the consideration of "Failure Mode Likelihood" on the Y-axis and "Failure Mode Consequences" on the X-axis with their corresponding rating on the scale of 1 to 5.

16. Risk Priority Number (RPN) A Risk Priority Number (RPN) is a numerical value used to assess and prioritize risks in a Failure Modes and Effects Analysis (FMEA). The RPN is calculated by multiplying three factors: severity, occurrence, and detection: Severity: How serious the consequences of a failure would be (link to end product failure) Occurrence: How likely the failure is to happen (Use of Historical data, similar processes) Detection: How likely the failure is to be identified before it causes a problem (Method use and historical data) RPN is calculated from severity of event (S), the probability of occurrence (O) and probability of detection (D) according to the following formula:  RPN = S × O × D.

17. Benefits of Quality Risk Management Here are some benefits of QRM: Maintains product safety: QRM helps ensure that products meet quality standards and regulatory compliance.  Optimizes resources: QRM helps optimize resource utilization and decision-making.  Resolves issues faster: QRM helps companies resolve issues faster.  Facilitates compliance: QRM helps companies comply with regulatory requirements Reduce business Threats: QRM helps companies identifying and controlling risks proactively before they cause problems.   P

18. Risk Management -in nutshell is a proactive approach Keep Practicing…………..

19. Thanks Dr. Ravi Kinhikar Ph.D. Quality Practitioner, Trainer, Certified QMS Auditor Email: [email protected] Call: [phone]