Product Quality & Safety

Product Quality & Safety

Patient safety is our highest priority. We are dedicated to developing and delivering safe and effective pharmaceutical products and medical devices that meet the needs of patients and healthcare professionals. Our comprehensive quality management system governs all aspects of drug and device manufacturing providing the foundation for safety that underpins our entire business.

We adhere to strict regulatory requirements, following Good Clinical, Pharmacovigilance, Laboratory, and Manufacturing (GxP) principles throughout our global operations and maintain certifications in numerous international standards to ensure that all our products are manufactured, tested and distributed according to the highest quality standards.

Quality Guiding Principles

Mallinckrodt’s dedication to Quality reflects our personal and corporate commitment to excellence. Our guiding principles are:

1. Patient Safety as the highest priority, pre-eminent in every decision we make.
2. Complying with applicable laws and regulations as well as internal requirements to position our company as a model for compliance and integrity.
3. Being recognized as an industry leader in providing quality products and services which meet or exceed the requirements and needs of our patients.
4. Continuously challenging ourselves to improve the quality management system, our Quality processes and operational excellence through the review and analysis of quality objectives and results.
5. Encouraging participation and promotion of quality responsibilities among all employees and third parties through education, training and coaching, supervision, and effective communication.

We are committed to communicating our Quality guiding principles to all employees and third parties, and to provide the required leadership, management, and resources to achieve our quality objectives.

Environment, Health & Safety (EHS)

At Mallinckrodt, we believe our commitment to protecting health, safety and our environment starts with a socially responsible culture. That’s why we remain focused on building safety and environmental excellence into all of our processes from start to finish.

In doing so, our expectation is an injury-free workplace and an assurance that our activities do not result in adverse safety, health or environmental impacts either on or off-site.

Our EHS Efforts

At Mallinckrodt, we are building a culture where environmental sustainability, as well as employee health and safety are promoted at every level within the organization. We believe that every employee is responsible for EHS - leading us to continuously improve our EHS performance by recognizing, evaluating and controlling risks. Some of the main features of our EHS efforts include:

• A well-established EHS management system, including internal protocols and standards adapted to meet or exceed compliance with applicable laws.
• Continuous improvement to become a more sustainable and responsible business.
• An enterprise-wide EHS management software with utilized and established metrics and measures, including both lagging and leading indicators, to evaluate and project company performance.
• An internal and external auditing program to assure compliance.

To access our Safety Data Sheets (SDS), please use our SDS search database.

Responsibility Supply Chain

We also strive to source goods and services from suppliers that share our promise of quality, innovation, customer satisfaction, diversity and sustainability. We expect our suppliers around the globe to adhere to the same high standards and policies that we set for ourselves. Learn About Becoming a Mallinckrodt Supplier

Click here to view our 2022 Sustainability report.