Ensuring Quality in Global Operations

May 5, 2017

Quality is part of everyone’s job at Mylan. We employ a combination of global systems and procedures as well as cultural and behavioral programs designed to help employees “do what’s right, not what’s easy” and give their best every day.

Mylan has invested significant resources to ensure quality throughout our value chain. Each of its steps is wrapped in a series of reviews, designed to meet or exceed the many regulatory and compliance standards enforced by the dozens of health authorities around the globe that regularly inspect us. The result is an integrated global network capable of providing pharmaceuticals that patients the world over can trust. Approximately 80% of the product volume we sell is produced through internally controlled manufacturing.

Working with business partners

We also rely on various third-party business partners to help us develop and reliably provide high quality products.

Partners provide us with certain R&D services; active ingredients, excipients and intermediates; manufacturing services; and packaging, distribution and other services and supplies.

We conduct due-diligence and site visits before agreeing to partner with a third party. We then revisit sites. Associated controls are vetted on a regular basis by an operations-focused internal audit team that applies standardized, objective assessments designed to evaluate best practices. Audits are performed at our locations and facilities as well as those operated by our external partners.

In 2016, we conducted more than 600 audits of existing and prospective suppliers, contract manufacturers, packagers and laboratories. Choosing which suppliers to audit is directed by our risk-management model. It balances a variety of factors, such as supply volume, our experiences to date with vendors and product type, e.g., injectables.

Our supply chain security program has been validated by the U.S. Customs and Border Protection agency, achieving the highest level of certification, Tier III status, within its Customs-Trade Partnership Against Terrorism program.

Learn more about Mylan’s operations and products.

Read more about Global Social Responsibility at Mylan