Because patients’ health and well-being are at stake, ensuring quality is essential for the pharmaceutical industry. That’s why, at Mylan, we view quality as being everyone’s responsibility.
For us, quality begins with product development, as we work to ensure an acceptable safety and efficacy profile for every drug we hope to market, and it extends through every step of the production process, from making or sourcing raw materials to producing finished dosage forms.
Externally we work with health authorities to help develop standards that reflect the requirements needed to develop and manufacture products. We then work hard to ensure that our sites, and those of third parties we rely on, comply with them.
Our manufacturing facilities are routinely inspected by various health authorities around the world. 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.
Our training programs, for instance, are designed to make sure employees are qualified by experience and education to perform their jobs in accordance with GMP. All employees responsible for GMP activities are required to take refresher training periodically.
Our Quality Council program provides management with clear, quantitative data, including that of key performance indicators. It also tracks and analyzes quality trends, reviews inspection results and identifies potential areas for employee training.