Quality systems and regulatory compliance | Avantor

Quality and compliance

Built on cGMP manufacturing and supply chain security

Quality is an essential element of every process, program, product and solution at Avantor and is the foundation for the value we deliver every day.

Beyond our own operations, we have robust supply chains and security programs with our suppliers. In addition, we track and share our performance with our customers, allowing you to benefit from enhanced regulatory compliance and minimized risk—driving cost-effectiveness and faster time-to-market for products.

Quality and regulatory expertise

We serve industries subject to rigorous quality, performance and reliability regulations. You can rely on us to navigate these requirements while also facilitating your innovation and manufacturing efforts. Product quality is assured by our quality systems, which begins with an effective design protocol and continues up the supply chain, from vendor qualification through product distribution.

We have filed and maintain over 800 master access files (“MAF”) and drug master files (“DMF”) that are registered with regulatory authorities globally—helping to simplify medical and pharmaceutical product approval processes by allowing manufacturers to reference our products as part of their own applications. 

cGMP manufacturing and cGDP distribution

Our cGMP facilities and ISO-certified manufacturing and distribution facilities create a network that is designed to meet stringent Quality and Regulatory requirements and standards. Our manufacturing strategy offers products made under relevant cGMPs. Learn more about our global footprint and capabilities.

Management of change (MOC)

Change is a constant in today’s global manufacturing environment. We help you stay in control of changing situations and minimize risk through robust Management of Change programs. Customer notification, helps you stay in control of changing situations and minimize risks associated with changes to manufacturing processes. Learn more about our MOC program.

Secure global supply chain

From the acquisition of raw materials through production and shipping, we emphasize Quality and Security in both our own operations and those of our suppliers. Key elements of these efforts include:

  • Supplier auditing and integrity: We conduct risk-based audits to understand the capabilities of new suppliers and collaborate with suppliers to promptly address corrective and preventive actions (CAPAs), should they arise.
  • Collaborative planning, forecasting and replenishment (CPFR): we provide service level reports on assurance of supply through our Critical Materials Care team
  • Documentation: Certificates of Conformance, Quality or Analysis are available with SDS documents on our websites