Our filters feature non-destructive integrity testing. In the rare event, that a Merck device performs in a sub-optimal manner, our staff can quickly and accurately retest and offer technical advice to resolve any issues.
We work with our vendors to ensure supply continuity for as long as is practical. However, product changes can and do occur. Notifications of Change and Quality Audits are two ways that Merck helps you navigate the hurdles of post approval change.
|Notifications of Change:
Because changes in a supplier's product can require re-validation of your manufacturing process, we know you need stable process materials. When evolving customer needs, changing regulations, or other factors require that Merck modify its products, our change notifications provide you with:
Merck's ultimate goal is to provide products and services that satisfy our customers' needs. To ensure our quality systems are operating as designed, we perform self audits. These audits provide us with ongoing internal communications that lead to improvements in our manufacturing processes.
In addition, Merck is routinely audited by external agencies such as the U.S. Food and Drug Administration (FDA) for compliance to the Medical Device GMP regulations, and internationally accredited registrars for compliance to the ISO® 9000 Quality Systems Standards.
Lastly, you, the customer, are welcome to visit or audit our worldwide manufacturing facilities to observe our Quality Management System in operation.
Moving your production to a new facility? Merck can help you make that migration quickly, while minimizing expense.
Let Merck’s experienced technical staff of scientists and engineers help you resolve issues as they arise. You can also leverage our collective experience and know-how to help you institute industry best practices.