FDA sends warning letter to KVK-Tech manufacturing facility
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
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A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
24 January 2025 | By LabVantage Solutions
Find out how to take advantage of a connected digital ecosystem to enhance quality control, streamline manufacturing and, ensure regulatory compliance
18 December 2024 | By MasterControl
This webinar explores the major trends impacting life sciences in 2025 and how the pharma industry can capitalise on the latest developments shaping quality management.
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
9 December 2024 | By European Pharmaceutical Review, sponsored by Charles River Laboratories
During this virtual panel, industry experts explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.
Troy Wright, Senior Vice President and Global Head of Quality at Abzena, shares an overview of current major challenges within pharmaceutical microbiology quality control, including the lack of staff knowledge in advanced technologies and how the sector’s importance can be overlooked, despite its key role in bringing safe, quality products…
IMA Pharma discusses approaches to keeping Amoxicillin and Clavulanic Acid tablets stable and effective by addressing moisture sensitivity and preventing degradation.
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
The innovative method uses spectroscopy and could enhance pharmaceutical quality assurance in resource-limited settings, the study suggests.
The system is distinguishable from other bacterial expression systems and can be applied in scenarios where minimal endotoxin contamination is an issue, according to the research.
26 November 2024 | By
A guide on what to expect during a regulatory inspection and the differences in the approach taken by three of the main regulatory authorities and PIC/S.
Analysis cites personalised medicine, outsourcing and digitalisation as some of the key factors set to advance the pharmaceutical analytical testing market to 2032.
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
This application note explores rapid microbial methods and balancing patient care, quality products, and safe shelf lives for unique formulations.
In this Guide to Outsourcing article, Jessica Rayser, Associate Director Product Management, Accugenix®, explores how outsourcing microbial identification can benefit technicians and facilitate the most accurate identification possible.