Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

ISO 13485 is the Medical Devices Quality Management System Requirements for Regulatory Purposes. ISO 13485 describes requirements that a manufacturer can be in one or more stages of the lifecycle of a ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

The US Food and Drug Administration (FDA) on Wednesday issued two draft International Council for Harmonisation (ICH) guidelines covering safety data collection and bioanalytical method validation for ...