Validating cleaning in a pharmaceutical manufacturing facility is a regulatory requirement (1–4). In regulatory guidance documents, program basics, regulatory expectations including prerequisites, and ...

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 ...

In-line UV spectroscopy allows real-time monitoring of cleaning processes, enhancing process control and compliance with Pharma 4.0 goals. The method provides continuous detection of residual cleaning ...

For pharma, maintaining stringent cleaning standards is non-negotiable. The stakes are high, and the margin for error is slim. Cross-contamination can compromise ...

A review of Olympus presentations to the U.S. FDA over its duodenoscopes suggests the Japan-based medical-device maker may have been "hoist with his own petard" in its attempt to have cleaning ...