Interview for web
- 1. Pharmaceutical Quality systems have shifted in recent years from a traditional model to a more global, dynamic and risk-based approach, enhanced especially by regulatory authorities and the economic environment. The integration of quality risk management is not anymore an option for pharmaceutical companies, which need to improve and strengthen the robustness of their process along the life cycle of their products to facilitate innovation, improvement and compliance. An effective quality system is also guaranteed by continual verification of the data, processes and products, which also need to be implemented within the global quality architecture. Ahead of Quality Risk Management & Process Validation in the Product Life Cycle Conference, we spoke with Michael Schousboe, Principal Specialist Quality Risk Management at Novo Nordisk, who analyses how a risk management approach can be implemented and deployed in the existing quality system. Could you please explain how a risk management approach can be implemented and deployed in the existing quality system? I think that the challenge of implementing a risk based approach across an existing quality management system is major because of the following: • The huge variety or spread in what QRM should be used for • The complexity of fitting in to existing systems which are already in function What we are facing, is an expectation to use QRM as a mean of obtaining a lot of different purposes. Authorities call QRM an enabler and I think the key to success here is to linger at exactly that statement. We need to figure out a way to manage risk by selecting or adapting methods that fit the value creation needed in the different activities. QRM has no value on its own. Only if you use it for something that can bring value, and the combination of domain knowledge and knowledge of QRM methods is what makes it work. When it comes to fitting into an existing and operating Quality Management System, I find that the key here is to stop considering QRM as something new. QRM is just systematic common sense, and the systems we already have running are built the way they are to protect our patients and ensure product quality. To a large extent most systems already utilise some form of QRM in the way they operate, if built according to the GMPs. However you may not be conscious about how it works. What I find, is that, once you acknowledge what is already there, and accept the other terms that may be used for what are essentially QRM activities, then you get to a value adding QRM integration. This way you will be able to use existing systems and reporting flows, and not create redundant activities. You may have to improve the choice of methods and alter the level of formality but that becomes a means to value creation rather than a purpose in itself. Which monitoring system can be the most efficient? That very much depends on what you are looking for. However, any system that gives you frequent data points on achievement of specific quality characteristics, or how the trends of these are moving, will provide value. What you want from a monitoring system is to see whether you are in control or not. If, for example, you are looking directly at manufacturing processes, then control charts of the individual process parameters and the quality of the output can be highly valuable as a monitoring system in order to see if the risk picture changes. How Novo Nordisk re-deploy a QRM program? Novo Nordisk originally deployed a QRM program when the ICH Q9 guideline came out, and so we have a risk based approach to many things across the Quality management system. However, some time back we understood that we were not realising the full potential of the concept. We had a tendency to choose the same fairly complex method for most uses, and we were not good at recognising the flexibility in terms of level of effort and formality. We could see examples where the QRM activities were becoming an add-on to other activities that sometimes was redundant. With a combination of knowledge about the business process and what should be achieved, and solid knowledge about QRM principles, methods and activities, we decided to re-deploy with a clear focus on integration in the existing business processes We want to achieve a future state where people do not implement QRM for the purpose of being compliant. They simply do the activities they should do to operate the business, with QRM seamlessly integrated in that. We make this a combined effort between our QRM experts and the persons responsible for each business process across the company. We can evaluate what is currently being done compared to the topics below, in order to identify potential for improvement: 1) Expected uses of QRM 2) QRM principles including choice of method 3) Clear integration of the steps of activities seen in ICH Q9 We are just starting, but we have already seen the first examples of this approach making more sense to users. What would you like to achieve by attending the Quality Risk Management & Process Validation in the Product Life Cycle conference? I hope to meet a lot of peers, to exchange both experience and ideas about integration of QRM across the Quality Management System, and have some good discussion about practical approaches and solutions. About the speaker: Michael Schousboe is Principal Specialist Quality Risk Management in Novo Nordisk. Situated in Corporate Quality, he has the overall responsibility for maintaining a well performing and compliant process of Quality Risk Management across the quality management system of Novo Nordisk. The past few years he has worked as a project manager improving the Quality Management System, and originally led the implementation of Quality by Design in Novo Nordisk. Michael holds a Master’s degree in pharmaceutical science (M.Sc. Pharm.) from the Royal Danish School of Pharmacy, a Design for Six Sigma Black Belt, and has 18 years of experience within the pharmaceutical industry. With a QC laboratory background and later as a QA professional Michael has worked with qualification and validation within the areas of computerised systems, laboratories, as well as production of drug products and API in different Danish pharmaceutical companies. He is experienced as a speaker on the aspects of QRM, validation, Quality by Design and Quality Systems. Furthermore Michael is an experienced auditor and has served as a qualified person About the event: This marcus evans conference will help delegates implementing a quality risk management approach into their existing quality systems, understanding how to assess and evaluate risks in their companies and with their Third party partners. They will also gain insights from various companies with the development of continuous process verification, approaching the management of data and preventing potential pitfalls in its implementation. Quality Risk Management & Process Validation in the Product Life Cycle Conference will take place from the 28th until the 30th of September 2016 in Berlin, Germany. For more information about the event, please click here or contact: Yiota Andreou T: +357 22849 404 E: Yiotaa@marcusevanscy.com How a risk management approach can be implemented in the existing quality system