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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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QA/QC
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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.
whitepaper
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.
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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.
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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.
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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.
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EMA recommends 15 medicines for approval following December meeting
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
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Application Notes & Whitepapers 2020
Industry experts share their latest research and developments in pharma.
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European Pharmaceutical Review Issue 6 2020
This issue focuses on whether our vaccine innovation capabilities will prepare us for future outbreaks, how Raman spectroscopy can be used to rapidly detect SARS-CoV-2 and the development of high-throughput glycoanalytics for biopharmaceuticals. Also included are articles on opportunities in the global API market and how to successfully identify defects…
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UK Government issues guidance after allergic reactions to Pfizer COVID-19 vaccine
Following reports of the Pfizer/BioNTech COVID-19 vaccine causing anaphylaxis, the MHRA has said those prone to allergic reaction should not receive the jab.
whitepaper
Whitepaper: Combining rapid and EP bioburden testing
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
