Customers enjoy buying from a small business that consistently delivers great products. However, the experience may last only a short time: Only two out of four small businesses survive beyond five ...

Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in 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 ...

This section should be read in conjunction with the interim process guide for a more proportionate approach to quality standard development The NICE quality standards team develops a topic overview ...

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality. Routine, ongoing assessment of process performance and ...

Good managers seek to contain costs in the manufacturing environment. There is no better cost to eliminate than the cost of poor quality. Scrap material and lost labor hours add no value to the ...

Improving the quality of clinical trials is a major strategic activity for Big Pharma, one where efficient management of a demanding set of regulatory requirements can have a positive impact on the ...

Out-of-Pocket Costs for Tyrosine Kinase Inhibitors and Patient Outcomes in EGFR- and ALK-Positive Advanced Non–Small-Cell Lung Cancer Literature review identified 226 unique measures from 23 measure ...