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Since the US Food and Drug Administration (FDA)’s report on a series of nitrosamine-related impurity drug recalls in 2018, pharma has made great strides in its ability to detect and control for these impurities. Dr Mrunal Jaywant, Vice President of R&D at USP India proposed a collaborative, cross-community approach between…
A roundtable panel discusses culture media regulatory requirements and how media specifications could impact your environmental monitoring program in aseptic manufacturing.
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
In this podcast, Allison Scott, Lynn Johnson and Miriam Guest discuss how cross-industry collaboration through working groups can support adoption of modern microbial methods.
30 May 2023 | By Medable
In this webinar, we dive into the intricacies of implementing electronic informed consent (eConsent) in clinical trials within the complex regulatory landscape of European countries.
A data-driven approach to optimise sanitisation and improve process control of the microbial parameter in a water system.
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
20 April 2023 | By Charles River Laboratories
Doug Botkin, PhD, examines the challenges and consequences of inaccurate microbial identification methods using real-world case studies and discusses how these challenges can be addressed.
Microbiology expert Tim Sandle’s recent video examined identifying the origin of fungi in pharmaceutical cleanrooms.
Reliable, intuitive and simple to use. Bringing ELGA's ultrapure water purification to GxP Quality Control Laboratories.
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
Technical Report 90: Contamination Control Strategy Development has been released by the Parenteral Drug Association (PDA).
