Commercializing in Canada: Quality Assurance and GMP Services
By AmerisourceBergen
Executive Q&A: Quality Assurance expert Stuart du Kamp talks about the need for QA to adapt to new industry trends, the benefits of a long-term quality improvement plan, and what manufacturers can gain from integrated solutions.
As pharma manufacturers work to bring new products to market in Canada, quality assurance (QA) is key. ‘It shouldn't be an afterthought or a quick fix, but rather an ongoing consideration’, says Stuart du Kamp, Senior Director of QA GMP Services at Innomar Strategies. In this interview, du Kamp discusses the importance of long-term plans for quality improvement and the benefits of integrating QA consulting with other services for commercialization in Canada.
Q: What is one industry trend that you think manufacturers should know about?
Stuart du Kamp: One of the biggest areas of opportunity we are looking at is gene therapy. Gene therapy, which involves modifying or replacing a patient's faulty gene, is still largely experimental, but there are a small number of products that are already on the market. With gene therapy, the generation of the product and the supply chain are very different than with a traditional medication. As new products come onto the market in Canada, there's going to be a need for quality oversight that is adapted to this new reality and we are ready to help, not just from a quality perspective, but also because of our intimate knowledge of the Canadian supply chain.
Q: What service do you provide that surprises manufacturers?
SDK: We work closely with Innomar's regulatory services group, which helps manufacturers prepare drug submissions that comply with both the FDA and Health Canada requirements. People don't necessarily think of quality assurance services when they think of regulatory, but there are a lot of projects that have a quality aspect to them. We have a team of consultants that are extremely knowledgeable, providing greater stability than an independent consultancy. Our clients benefit from the fact that we are part of Innomar, a large integrated company, with the resources to meet a wide range of needs.
Q: How does your team generate value for the manufacturer?
SDK: A lot of people in consulting are career consultants. On my team, we have the right balance between experience in consulting experience and experience within an operations environment. It allows us to provide a different perspective. A consultant can give you something that sounds great on paper, but may not be practical to implement. Instead of looking for the quick fix, we focus on what I call relationship consulting. It's about getting to know the client and learning what their needs are, as opposed to trying to impose what we think they should be. A lot of companies are fearful of QA because they are seen as intransigent, as black and white. However, at Innomar we aim to be flexible and work closely with our clients. Sometimes, it's necessary to create a phased, multi-year approach to implement a solution and improve quality on an ongoing basis.
