A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals. It is now possible, as demonstrated by Janssen (1), for drug ...

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...

Discover how automation is revolutionizing laboratory processes, changes in the regulatory landscape, and how labs can stay ahead in this article by Brent Hart.

Qualification/validation can be defined as “establishing documented evidence which provides a high degree of assurance that specific equipment procured will ...

Amidst reports of doubtful credibility of manufacturing standards followed by some of the pharma companies in the country, particularly with reference to Ranbaxy, Hospira and Wockhardt, topics like ...