Maintaining Quality in Everything We Do
For us, quality begins with product development and extends through every step of the production process. Externally we work with health authorities to help develop standards that reflect the requirements needed to develop and manufacture products. We then work to ensure that our sites, and those of third parties we rely on, comply with them. In 2017,128 inspections were performed across our facilities and affiliates. Mylan has global systems and processes in place to provide our people with the foundation and tools needed to maintain an effective quality management system and our Quality Council program provides management with clear, quantitative data, including that of key performance indicators.
Quality Within Our Supply Chain
Maintaining access to high quality raw materials and delivering finished goods in a timely manner are crucial to Mylan’s ability to provide patients with access to the medicines they need. Mylan’s global supply chain has been strategically designed to ensure that the right products reach the right customers (and ultimately patients) at the right time. Many of our facilities are in close proximity to the markets we serve, as shown below, and about 75% of the product volume we sell is produced through internally controlled manufacturing. To manage this network responsibly across many markets and engage with health authorities around the globe, we have a robust set of quality systems and controls in place. We also engage our suppliers and partners to address the full range of quality-related considerations involved in developing and manufacturing drugs, and we have quality agreements with our suppliers. In addition, we seek full compliance with all applicable laws, such as those focused on labor, the environment and anti-corruption for both our internal and external network of suppliers. We also make investments as appropriate to keep employees safe, the environment clean and quality high.
We also have procedures to monitor supplier compliance and mitigate potential concerns. We conduct audits of new and existing suppliers and contractors – as well as potential partners – as part of our due-diligence effort. We prioritize and set schedules for quality audits across different geographies based on criteria that include:
► Type of operation and services provided;
► historical regulatory inspection performance;
► significance to Mylan’s business and product launches; and
► periodic audit requirements.
Our scientific affairs, operations and quality teams oversee an extensive distribution network of internal and external partners, helping to enable Mylan to meet customers’ needs safely, securely and in a timely fashion.