Putting quality first in development and manufacturing
Capsugel’s Steven Facer says prioritisation of quality and regulatory compliance from the start is key to achieving long-term gains for emerging markets
Between 2014 and 2018, pharmaceutical sales in EMEA emerging markets, including Africa, Eastern Europe, the Middle East and Russia, are projected to increase by more than 35 per cent, representing $29 billion in new sales [1]. While this explosive growth represents a significant opportunity for pharmaceutical companies based in these markets, it also presents new challenges.
After years of importing medicines, the local pharmaceutical industry is growing in many emerging markets, fueled by local entrepreneurs and the opportunity to develop an independent and local drug supply. As the nascent industry develops, it is confronted with an evolving regulatory environment that is quickly adopting stricter and more stringent criteria. International developers and manufacturers of dosage forms such as capsules, with established roots in Western Europe and the US, are well positioned to help pharmaceutical companies in emerging markets with their local business needs.
First, international dosage form developers and manufacturers have a business model that prioritises quality and regulatory compliance. These companies allocate resources to quality management that are integral to their offering and cannot be minimised or reallocated. The investment in developing and manufacturing quality dosage forms is a baseline for doing business in the pharmaceutical industry. This is an approach that the industry in emerging markets is striving to embrace more and more.
This commitment to maintaining the highest quality standard requires recognition that investing in quality can have a much more positive impact on margins, reputation and other factors than the short-term gains achieved by offering lesser quality products at lower costs. By investing in quality from the start, these manufacturers are able to more often avoid costly recalls or regulatory fines, among other issues.
Second, dosage form developers and manufacturers based in developed markets maintain the highest level of quality manufacturing processes and standards. These companies place quality at the core of all of their management and operational processes. They also pour significant resources into product quality systems, from the earliest stages of product development through the manufacturing process. This includes the creation and implementation of quality by design (QbD) processes and good manufacturing practices (GMPs) to help maintain quality and realise efficiencies throughout product development.
At Capsugel, we have adopted a comprehensive quality risk management approach — centred on traceability, safety and integrity through the whole supply chain process — to help ensure consistent compliance with the highest industry standards in every market. Capsugel was recognised for its commitment to quality as the first hard capsule manufacturer to be awarded with EXCiPACT certification for its sites in Europe — an independent validation that Capsugel maintains excipient GMPs and complies with European regulations in manufacturing empty two-piece hard capsules.
Third, international dosage form developers and manufacturers have decades of experience collaborating with large pharmaceutical organisations in the development of their products. Based on this expertise, these companies can assist organisations in emerging markets throughout the product lifecycle, from fast track development support through to a customised supply chain programme for commercial drugs. Also, these companies can support innovation with customised capsule design or formulation using, for example, bioenhancement technologies.
At Capsugel, our value proposition is tied to the comprehensive support we deliver to our pharmaceutical customers in emerging markets as an integrated solutions provider. Our service offerings include:
• Commercial team support that understands local business practices, so that business is conducted efficiently and seamlessly.
• Scientific and product development support that address questions related to dosage form development and scale up.
• A full array of supply chain programme services to ensure optimal delivery times.
• A readily available technical service team that helps customers develop and implement a flawless manufacturing process.
• Regulatory support that tracks and analyses the latest global and local regulations and stays in close contact with authorities across markets, so customers can anticipate and adapt to any regulatory change with minimal impact to their business.
• Market development specialists who build and leverage their relationships with local players for insight on global industry trends and best practices, which can translate into new business for customers.
As both business opportunities and regulatory regulations in emerging markets continue to evolve, local pharmaceutical companies need global dosage form solution providers as partners with the commitment, locally accessible knowledge and experience to put quality and compliance first and fully optimise their growth opportunities to compete within the local and global pharmaceutical market.
Reference:
[1] IMS Market Prognosis 2013–2018.