Quality Risk Management
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1 Quality Risk Management Iron Chef Edition Keith D. Gibbs kage and sui generis Ninja Project Management My story shapes my perspective Bachelor of Science work in Earth Science with focus on Hydrogeology. Masters of Science work in Coastal Policy and Marine Resource Management. PhD and JD work in Environmental Policy. Twenty five (25) years experience with regulated industries, with the first seven (7) years in Environmental Science and the last eighteen spent in Pharmaceutical & Biotech Manufacturing. Fifteen (15) years as a Project Manager, getting further and further away from the details of issues, but closer and closer to the impact that misunderstood issues have on large projects. 1
2 My story shapes my perspective When I was in the Air Force ROTC as a meteorology major, I looked at the physics of airflow at a global scale, in open systems. My story shapes my perspective After shifting to the geosciences, my focus became more environmental policy and I worked in air quality for the EPA 2
3 My story shapes my perspective When I was in the lab, I looked at EVERYTHING under the microscope, and debated and discussed every possibility ad nauseum. My story shapes my perspective As a young Validation Specialist, I was trained to look for failure, but rarely asked to provide reasons for that failure. Discrepancy resolution fell to others, and those resolutions were often on different timelines then mine. 3
4 My story shapes my perspective As a Project Manager in pharmaceutical manufacturing, I now focus more on programmatic solutions, quality by design, Quality Risk Management and avoidance of regulatory observations. Sometimes the view of root cause gets clouded when you are looking at everything from the 30,000 foot level. My Days Are Spent 8 4
5 Facility Design What Is The Driver? #1 -PROTECTING THE PRODUCT! 9 PROTECTING THE PRODUCT MEANS PROTECTING THE PATIENT Surfaces should not be REACTIVE ADDITIVE ABSORPTIVE 10 5
6 PROTECTING THE PRODUCT MEANS PROTECTING THE PATIENT So as not to alter SAFETY STRENGTH QUALITY IDENTITY PURITY 11 THERE ARE OTHER REASONS 12 6
7 FACILITY DESIGN AND CONSTRUCTION GENERATES? 13 7
8 INTRODUCTION TO QUALITY RISK MANAGEMENT Video Clip 8
9 History Pharmaceutical cgmps for the 21st Century A Risk-Based Approach: Second Progress Report and Implementation Plan On February 20, 2003, the Food and Drug Administration (FDA) released its first progress report on a major initiative concerning the regulation of drug product quality. The 2-year initiative, Pharmaceutical cgmps for the 21st Century: A Risk-Based Approach (the Pharmaceutical cgmp initiative), which was launched on August 21, 2002, applies to human drug and biological drug products and veterinary drugs and has several objectives: 18 9
10 Pharmaceutical cgmps for the 21st Century A Risk-Based Approach: Second Progress Report and Implementation Plan To encourage the early adoption of new technological advances by the pharmaceutical industry To facilitate industry application of modern quality management techniques, including implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance To encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas 19 Pharmaceutical cgmps for the 21st Century A Risk-Based Approach: Second Progress Report and Implementation Plan To ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science To enhance the consistency and coordination of FDA's drug quality regulatory programs, in part, by integrating enhanced quality systems approaches into the Agency's business processes and regulatory policies concerning review and inspection activities
11 More History International Conference on Harmonisation Began in 1990 Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. ICH's mission is to achieve greater harmonisation so safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. ICH
12 ICH Q9 QUALITY RISK MANAGEMENT This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, biological and biotechnological products Development Manufacturing Distribution Inspection submission/review processes Includes: raw materials, solvents, excipients, packaging and labeling materials 23 ICH Q10 PHARMACEUTICAL QUALITY SYSTEMS ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. based on International Standards Organisation (ISO) quality concepts includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk Management. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional
13 Even More History GROUPS/AGENCIES THAT ISSUE GUIDELINES American Society for Testing and Materials (ASTM) development and delivery of international voluntary consensus standards. (Over 12,000!) improve product quality enhance safety facilitate market access and trade build consumer confidence
14 ASTM E Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Application of the approach is intended to satisfy international regulatory expectations ensures that manufacturing systems and equipment are fit for intended use. satisfy requirements for design, installation, operation, and performance. The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cgmps for the 21st Century A Risk-Based Approach. This guide supports, and is consistent with, the framework described in ICH Q8 and ICH Q9. WHAT DOES ALL THAT GUIDANCE DO? CONSUMER cgmp s Finished Goods Manufacturers Contract Manufacturers Raw materials API Manufacturing Packers & Handlers 14
15 The Future? Video Clip 15
16 PROCESS THINKING The key to understanding the topic Process Thinking 16
17 Process Thinking A documented, standardized set of steps to accomplish an objective. Documented And Standardized Processes Most processes are neither documented nor standardized. A documented process is one that has been explicitly described graphically or in text. A standardized process is one that has been made common across a number of performers; doing the same thing in a common way. Without documented and standardized processes people can work towards a common outcome in any number of ways. 17
18 Documented And Standardized Processes Example the members of one department responsible for sales and service in one district may do their job following different procedures than another department doing the same thing in another district. Two teams may achieve their similar project outcomes using different tools and approaches. The process can be made common so that everyone does their work in the same way, using the same tools and templates, following the same steps. Why Document And Standardize Processes Processes are any set of steps, documented, standardized or not. Documented and standardized processes are quite desirable. They are necessary parts of achieving high-quality results. Documented processes can be analyzed, evaluated, refined, standardized and made repeatable. 18
19 Why Document And Standardize Processes According to W. Edwards Deming: If you cannot define what you are doing as a process, you do not understand what you are doing. If you do not understand what you are doing, you are more likely to do it poorly inefficiently and ineffectively. Documentation is not the process. The documentation describes the process; it is not the process itself. Knowing this helps performers in complex processes to expect that they should and must not stop thinking, following the process blindly. Process documentation should clearly state the risks of following and not following the process as it is written. Standardized And Repeatable Processes Processes that are used across multiple departments or by many people make training more efficient are easier to control and improve enable easy transfer of people between departments or projects. Standardized processes are repeatable. They can be done the same way over and over again. 19
20 Standardized And Repeatable Processes Standardization and repeatability are great, but they come with a warning. Make sure they are good. Clearly, you don't want to repeat a process that is ineffective or inefficient. You need to bring process quality into the picture. In addition, you must consider the conditions and build in alternative paths to address predictable alternative situations. As said, the best people can be brought down by a bad process. Process Thinking 20
21 Selection of Volun Tolds QUALITY RISK MANAGEMENT ICH Q9 Quick Video 21
22 QUALITY RISK MANAGEMENT IS LIKE WORKING IN A RESTAURANT INTRODUCING QRM: IRON CHEF 22
23 SOME FUNNY VIDEO CLIPS TO FURTHER OUR DISCUSSION THE PREP 23
24 THE PRODUCTION THE JUDGEMENT 24
25 QUALITY RISK MANAGEMENT: LESSONS LEARNED BY YOUR SPEAKER Q&A 25
26 And what about that crazy conspiracy theory? For further information please contact: Keith D. Gibbs kage and sui generis Ninja Project Management 26
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