news
FDA monitoring impact of SARS-CoV-2 mutations
The FDA has alerted clinical laboratory staff and healthcare providers that it is monitoring the potential impact of SARS-CoV-2 mutations, including the UK variant.
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QA/QC
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Innovation in real-time next-generation sequencing provides pharmaceutical benefits
Tim Sandle explains how next-generation sequencing (NGS) could aid in the development of novel antimicrobials to overcome multi-drug resistance.
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Rapid microbiology testing market set to be worth over $6 billion in 2026
Rising at a CAGR of 8.2 percent, the rapid microbiology testing market is predicted to grow over the next five years.
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Glove prints are the most effective microbiological monitoring method during aseptic handling, finds study
Researchers evaluate the various microbiological monitoring (MM) methods employed inside a laminar airflow or safety cabinet in hospital pharmacies.
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Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
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On-demand webinar: Best practices for cleaning and disinfection
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
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Microbial surface recovery superior for vinyl than stainless steel
Researchers have shown that microbial surface recovery using contact plates was superior on vinyl than stainless steel.
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Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
news
Concerns raised over India’s approval of COVID-19 vaccine with incomplete data
The All India Drug Action Network has said it is "shocked" India has given approval to Covaxin, a COVID-19 vaccine with a lack of peer reviewed safety and efficacy data.
news
Oral hormone therapy found to alter metabolome of postmenopausal women
Research has shown oral hormone therapy significantly impacts the metabolome of postmenopausal women, explaining certain disease risks.
article
Pharmaceutical bottle packaging – the quest for zero defects and data integrity
This article shares the results from an evaluation of a novel thermal imaging technology that took place before the initial implementation in a Pfizer manufacturing facility. The manuscript describes the technology and reviews the extensive process used to challenge its inspection capabilities through field testing. Finally, the potential benefits of…
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Recent improvements in deep ultra-violet fluorescence devices for cleaning verification
Since their debut, the range of applications for which deep ultra-violet (DUV) handheld devices are used in the pharmaceutical setting continues to grow. For pharmaceutical or biopharmaceutical cleaning verification, there is a requirement for a versatile and adaptive analytical and imaging device to demonstrate and document cleaning cycles. Here, Krishnakumar…
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Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon and conductivity data
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
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Where now with quality by design?
Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
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QA/QC & Analytical Techniques In-Depth Focus 2020
In this in-depth focus find out why deep ultra-violet (DUV) handheld devices could replace current onsite cleaning verification applications and how Raman spectroscopy could be used to improve COVID-19 detection.
