Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

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 ...

The Medical Validation Procedure is very critical to verify that the system offers repeatability, assurance of accuracy, and a high degree of quality, according to a release from MTMS. The company ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

Single-use bioreactors have been successfully implemented by the biopharmaceutical industry up to the 2,000-L scale. The performance of single-use bioreactors is comparable if not superior to ...