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 ...

Whether you're making cookies or computers, your product should provide consistent high quality to your customers. The term "quality assurance" describes all the processes and procedures involved in ...

ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis iCMC™, ...

Validating drug production processes need not be a headache, according to AI researchers who say machine learning (ML) could be a single answer to biopharma’s multivariate problem. The FDA defines ...

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 ...

The Workshop is planned to highlight, review, and discuss issues related to the implementation of XRF methodologies, including addressing recommendations for compliance to technical requirements of ...

The draft guidance allows flexibility in using advanced technologies for drug product integrity and batch uniformity, potentially reducing reject rates. Concerns were raised about the definition of ...