Defining Risk and Risk Levels
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1 Defining Risk and Risk Levels Implementing ICH Q9 Quality Risk Management Gamal Amer, Ph.D. Premier Compliance Services, Inc. All rights reserved. Do not copy without permission. 1
2 Why Risk Management in Drug Manufacturing FDA Initiative August 2002 Pharmaceutical CGMP for the 21 st Century: A Risk-based Approach A science and risk-based approach to product quality regulation incorporating an integrated quality system approach All rights reserved. Do not copy without permission. 2
3 FDA Initiative August 2002 Take home: You must understand what you are doing. You must focus on critical areas (highest risk to product quality) of your operation. You should utilize automation and data collection to reduce risk associated with the operation and allow for continuous improvement. You must build the quality into your operation. All rights reserved. Do not copy without permission. 3
4 FDA Initiative August 2002 Its Objectives Allows Early adoption of new technology. Adoption of modern quality management techniques and implementation of the quality system approach. Focus on understanding the science & technology associated with what you are making. Priority to mitigating the highest risk elements of the manufacturing operation. All rights reserved. Do not copy without permission. 4
5 Risk What Is Risk? What Causes It? Risk to Whom? Risk Manifestation? Risk Level? All rights reserved. Do not copy without permission. 5
6 Risk Risk is always present in every endeavor. We as humans learn about it, recognize it subconsciously, and accept a certain level of risk on a daily basis. We always take steps in daily life to mitigate the risk associated with our activities. All rights reserved. Do not copy without permission. 6
7 Quality Events Which May Cause Increased Risk A problem occurs during clinical trials (patient complains/suffers) A deviation occurs during the manufacturing Analytical result is not what was expected A piece of equipment is identified as malfunctioning after the operation is complete. All rights reserved. Do not copy without permission. 7
8 Events Potentially Increasing Risk No negative quality event occurred, but: Patient complaints show a negative trend. Operation drifting towards action limit. Analytical data trending towards unacceptable. All rights reserved. Do not copy without permission. 8
9 These Events Pose: Risk to the patient/public Risk to the product Risk to the personnel Risk to the company All rights reserved. Do not copy without permission. 9
10 What Is Risk? The combination of the probability of occurrence of harm and the severity of that harm.* *ICH Consensus Guideline; Q9 Quality Risk Management; June 2006 All rights reserved. Do not copy without permission. 10
11 Risk is Always Present: Risk to the patient/public (Drug Side Effects, Adulterated Drugs) Risk to the product (Contamination) Risk to the personnel (Potent Compounds) Risk to the neighbors and environment (Explosion, Release Objectionable to Atmosphere) Risk to the company (Regulatory Recalls) All rights reserved. Do not copy without permission. 11
12 Risk to whom? We are concerned here with the risk to the quality of the product and hence to the patient. We will focus on the risk in the product lifecycle in general and in the manufacture lifecycle in particular. We will focus on GMP and quality systems as used to mitigate risk. All rights reserved. Do not copy without permission. 12
13 Higher Risk Manufacturing Operations Aseptic Processing (Contamination of product) Dealing with potent compounds (danger to patient from wrong formulation) Solid dosage (Cross contamination) Labeling (Wrong labels) All rights reserved. Do not copy without permission. 13
14 Defining Level of Risk Function of: Severity Frequency Detectability These three factors determine the numerical Risk Priority Number (RPN) Qualitative risk (low, medium, and high) All rights reserved. Do not copy without permission. 14
15 Risk Level Factors: Severity What are the consequences of the quality event (non-conformance or deviation)? How deleterious is a potential failure/deviation? How high is the risk to the patient s well being? All rights reserved. Do not copy without permission. 15
16 Risk Level Factors: Frequency What are the probability of the occurrence of the failure/deviation? Were attempts made to reduce such frequency? How successful? Review product history. All rights reserved. Do not copy without permission. 16
17 Risk Level Factors: Detectability What is the probability of the failure/deviation being detected? Can the effect/result of the failure/deviation be readily measured/seen? All rights reserved. Do not copy without permission. 17
18 Developing Risk Priority Number RPN Severity: Could result in the manufacture of a product, which may cause death or serious harm requiring intervention(3) product that may cause or contribute to a patient discomfort or an insignificant delay or interruption in treatment. (2).. product that will NOT cause injury or discomfort, or delay/interruption in treatment. (1) All rights reserved. Do not copy without permission. 18
19 Developing Risk Priority Number RPN Frequency: Would definitely occur, is known to have occurred in the past, expected to reoccur if no action is taken to correct or prevent the problem. (3) Unlikely to occur or not expected to reoccur, but it is possible. (2) Will not occur or is highly unlikely to.(1) All rights reserved. Do not copy without permission. 19
20 Developing Risk Priority Number RPN Detectability: Consequences of the events are not detectable or readily obvious (3) Consequences of the event are not obvious but, there is a good possibility that, it will be detected.(2) Consequences of the event are detectable (1) All rights reserved. Do not copy without permission. 20
21 Developing Risk Priority Number RPN Risk Priority Number (RPN)= Severity X Frequency X Detectability RPN= 1-4 RPN= 5-13 RPN= Low Risk Medium Risk High Risk All rights reserved. Do not copy without permission. 21
22 Mitigating Risk The level and extent of actions to be taken to eliminate or minimize actual or potential risk must be appropriate to the magnitude of the problem and commensurate with the level of risk anticipated. (ICH Q9) All rights reserved. Do not copy without permission. 22
23 Mitigating Risk CAPA as a risk mitigation quality system after the fact (Quality event occurs, investigate and correct or prevent). QbD as a-priori risk mitigation technique (Define risk early and design it out). PAT as a technical risk mitigation solution during the operation (Automate and reduce human intervention; Models adjust to correct potential manufacturing issues; Learn from data collected and apply to QbD). All rights reserved. Do not copy without permission. 23
24 Risk Level and Appropriate Action CAPA Action(s) Risk Level (RPN) Low Medium High No Further Investigation, No Corrective action required No Further Investigation (Cause Evident), Corrective action required Further Investigation (Root Cause Analysis), Corrective action required (Immediate; e.g.. Recall), Prevent Cause All rights reserved. Do not copy without permission. 24
25 Risk Assessment Form Page one: Product information Information for event or potential Risky situation Description of issue Description of the findings of any investigation Description of relevant historical information All rights reserved. Do not copy without permission. 25
26 Risk Assessment Form Page two: Analysis of Severity Analysis of Frequency Analysis of Detectability Page three: Calculation of RPN Definition of action to be taken All rights reserved. Do not copy without permission. 26
27 Risk Assessment Form Actions to be taken: High RPN - Intolerable Investigate and define root cause Reduce or eliminate risk of further occurrence Corrective action must be initiated immediately Medium RPN Tolerable Evaluate event Determine if additional investigation is warranted Conduct reasonable and practical corrective action Low RPN Negligible No additional investigation Monitor through trend analysis for further occurrences All rights reserved. Do not copy without permission. 27
28 Using The Risk Assessment Form Tylenol scare of the 1980s: Several death due to tampering with product capsules. The event happened twice. Consumer unable to recognized capsules tampered with. All rights reserved. Do not copy without permission. 28
29 Using The Risk Assessment Form Severity: Highest Result in death (3) Frequency: happened twice, does not happen often, will surely happen again (2+) Detectability: Difficult to detect a capsule that was tampered with (3) RPN: 18 or higher All rights reserved. Do not copy without permission. 29
30 Using The Risk Assessment Form Corrective Action: Investigation: Preventive action: Immediate recall Unable to protect capsules - Eliminate the use of capsules. - Develop Tamper evident packages All rights reserved. Do not copy without permission. 30
31 Risk Assessment: Part of CAPA and Continuous Operations Improvement When quality events occur during manufacturing the root cause is identified based on the assessment. One can then develop a solution to reduce or eliminate the risk thus improving the operation. Implementing the solution requires a Change Control system to be in place. Once solution is implemented one needs to monitor to ensure no new risks were introduced All rights reserved. Do not copy without permission. 31
32 In Summary All human endeavors have risk associated with them. Actions to be taken should be based on the assessment of the risk itself and commensurate with its level Reducing or eliminating risk is in itself a way to improve the quality of the product. Risk can be addressed a-priori (QbD) and/or after an event (CAPA) All rights reserved. Do not copy without permission. 32
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