Quality Risk Management Training Session for Cyclone Pharmaceuticals Pvt. Ltd.
Join Sachin Bhalekar at Cyclone Pharmaceuticals Pvt. Ltd. in Pune for an insightful training session focusing on Quality Risk Management. Explore ICH guidelines, risk assessment, and the importance of quality in pharmaceutical processes. Understand the significance of systematically managing risks to ensure the quality of medicinal products throughout their lifecycle. Gain insights into quantifying risks and categorizing severity levels for effective risk management.
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Presentation Transcript
TODAYS TRAINING SESSION IS FOR QUALITY RISK MANAGEMENT BY SACHIN BHALEKAR CYCLONE PHARMACEUTICALS PVT. LTD. PUNE
AGENDA The ICH process 1 ICH Q9 and other ICH guidelines 2 Risk to Quality Risk Management 3 Opportunities, Challenges and Benefit 4
ICH GUIDELINES Q1 Stability Q2 Analytical Validation Q3 Impurities Q4 Pharmacopoeias Q5 Quality of Biotechnological Products Q6 Specifications Q7 Good Manufacturing Practice Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality Systems Different: - not a recipe - not a SOP just a guidance
Definition Degree to Degree to which a set of inherent properties which a set of inherent properties of a product, system or process of a product, system or process fulfills requirements fulfills requirements Quality Combination of the Combination of the probability of harm and the of harm and the severity probability of occurrence of occurrence severity of that harm of that harm Risk Systematic Systematic process control, communication and review control, communication and review of risks to the quality of the drug (medicinal) product the quality of the drug (medicinal) product across the product lifecycle across the product lifecycle process for the for the assessment, assessment, Management of risks to
From Risk to Quality Risk Management What does it mean? What is it worth? Where does it lead?
Quantitatively: The risk shall be provided with numerical values 1 , 2 , 3 , 4 and 5 Severity of risk shall be categorized Category Description Score Very significant and having catastrophic impact on 1 Critical product Significant losses and require timely addressable High 2 management intervention required Loss of operating capability, long term of problem causes Moderate 3 adverse effect Impact on operations and efficiency, but limited effect Very minor or no impact on operational efficiency Minor 4 Insignificant 5
Likelihood of risk shall categorize Category Description Score Is expected to occur in most circumstances Almost certain 1 Will probably occur in most circumstances Likely 2 Will probably occur at some time Possible 3 Could occur at some time Unlikely 4 May occur in exceptional circumstances Rare 5
RISK BASED CONCPET & PRINCIPLES Pharmaceutical Development Pharmaceutical Development (Q8) (Q8) Past: Present: Data transfer / Variable output Knowledge transfer / Science based / Consistent output Quality Risk Quality Risk Management (Q9) Management (Q9) Pharmaceutical Pharmaceutical Quality Systems (Q10) Quality Systems (Q10) Past: Used, however poorly defined Present: Opportunity to use structured process thinking Past: Future: Quality Systems across product life cycle GMP checklist
How Q9 interacts with Q8 and Q10 Risk from Manufacturing site High Q10 Pharm. Quality Systems continual improvement Using Q9 Quality Risk Management principles Low Q8 Pharmaceutical Development Low High Product / Process Risk
ICH Q9 Link back to patient risk Opportunities to impact risk using quality risk management Q9 Design Process Materials Manufacturing Facilities Distribution Patient Q8 Q10
Quality Risk Management Process Understanding Regulatory Submission Regulatory Inspections Quality System PAC to continuous improvement Risk Process Understanding Regulatory Submission Regulatory Inspections Quality System Post Approval Changes(PAC) Risk Process Understanding Regulatory Submission Regulatory Inspections Quality System Continuous improvement Risk Q10 & Q9 Q8 & Q9
The investigation of risks is at once a scientific activity and an expression of culture
Risk Management as a discipline provides multiple benefits Understand and influence the factors (hazards) which impact regulators and industry business Create awareness and a culture Supports an effective pro-active behaviour Open factual dialogue Make decisions traceable and consistent Provide assurance Risks are adequately managed Compliance to external and internal requirements Recognise risks at a desired level Zero risk not possible
The Hurdles Growing complexity and scope of risks Globalisation Multinational Multi-factor approaches Regulatory expectations Acceptance of risk and uncertainty Increasing external requirements for best practice, transparency and compliance Public / Community Governments Regulators Patients Investors / Creditors ? Increasing efforts and costs for sustainability Documentation Projects Systems Interfaces
Empowerment & Flexibility An appropriate integrated approach helps to meet requirements more efficiently Improve communication through sharingbest practice and science based knowledge Quality Risk Management Proactive disclosure build trust and understanding Master complexity Convert data into knowledge e.g. by using methodology and tools
Risk Management across the Product lifecycle for drug (medicinal) products Research Preclinical Phase Clinical Phases End of life cycle Launch Manufacturing & Distribution Safety GLP GCP GMP GDP Efficacy Quality ICH Q9
Managing the risk of drug (medicinal) product use ICH Q9 Known Side Effects Medication or Device Error Product Defects Avoidable Unavoidable Efficacy Quality Safety Preventable Adverse Events Unexpected Consequences Injury or Death Public Health
The Risk-based approach Parameters for evaluating risks probability severity
Parameters for Calculating risks A picture of the life cycle Severity Probability x Detectability x = Risk Priority Number Refers to Refers to Refers to past today future time
Hazards in Quality System Defect Potential threat Failure Technical Breakdown Not Detected Chemical Reaction Insufficiently Prevented Manufacturing Issues Facilities & Requirement Human Breakdown Emerges by degree Extrinsic Effect Anything that has the potential to harm patients, product quality or the business (loss, interruption, image)
Has QRM already been implemented? Yes, however we need to firm-up and set the priorities in relation to risks We need to know How good is our QRM compliance and decision making? To what extent QRM has to be implemented or formalised? An then focus efforts and communicate in order to Avoid duplication of effort and to align initiatives Develop scope by using different viewpoints e.g. from management, internal and external customers
Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable Risk Management tools Risk Communication Risk Control Risk Reduction Risk Acceptance Output / Result of the Quality Risk Management Process Risk Review Review Events
COMMUNICATION Preliminary Hazard Analysis FTA Fault Tree Analysis FMECA Failure Mode, Effects & Criticality Analysis FMEA ICH Q9 Quality Risk Management Failure Mode Effect Analysis TOOLS PRODUCTION Hazard Operatibility Analysis MATERIALS Hazard Analysis & Critical Control Points QUALITY SYSTEM
Manage quality risks! What if disaster happens? Consequences Prior use of QRM may lower the consequences Nowadays QRM Using QRM Quality management as function of time
Implementing ICH Q9 means The weakest chain will no longer be a problem
Integrate QRM during product life cycle Gain experience Analyse root cause: Continuous improvement (Risk of) Failure ? Manufacture for market Quality Risk Management (QRM) Improve it Do, what you say Update documentation Approval Say, what you do
Risk & Uncertainity Tomorrow ? Process Parameter Uncertainty Upper Specification Limit (USL) Lower Specification Limit (LSL) today Time RISK: For a given severity of risk event, what are the chances (probability) of exceeding the USL in the next period of time?
Control Mitigation control of risk shall categorize as Description Insufficient information to adequately assess and rate the Category Score Not aware 1 control No mitigation plans in place mitigation plans though in place do not ensure adequate Not existent 2 Not effective 3 control over risk occurrence/impact mitigation plans involve is effective against the identified risk of HVAC, although chances of occurrence minimize, but there Effective 4 is very less possibility of occurrence of identified risk mitigation plans involve high degree of control on the operational procedure and is effective against all identified Very Effective 5 risk
Identified risk with severity, likelihood and mitigation shall club together to provide the overall picture of risk assessment Identification of Analyzing the Evaluation Risk Quantitative Qualitative Risk Risk Involved Risk of risk Reduction Evaluation Evaluation Sr. no Identifica Severity of risk Likelihood Mitigation Risk tion No. Description Total score impact Risk plan (control) category
