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 ...
Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes. Cleaning validation for biologics ...
The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...
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 ...
The main purpose of Quascenta’s recently launched software application – eResidue – is to replace spreadsheets. Spreadsheets require manual input; they can suffer from calculation errors and there are ...
In this free webinar, learn how cleaning validation inefficiencies silently undermine overall equipment effectiveness (OEE), and how to fix them. Attendees will learn how capabilities like part-level ...
Developing a cleaning validation for a reusable medical device presents several challenges. How are you addressing them? "There have been many issues over the last 7 years, so there's increased ...
Colorless, translucent appearance eases visual inspection and cleaning validation of critical processes equipment Garlock, a leading manufacturer of high-performance fluid sealing products, has ...
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