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New report shows strong performance in the dose CMO industry
The dose CMO industry is performing strongly despite challenges of increasingly complex drug production, says a new report.
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Drug Manufacturing
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Pharmaceutical residues risks need to be evaluated, says report
A new report has said the majority of the active ingredients used in pharmaceuticals have never been evaluated for environmental risks.
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ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management
The International Council on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.
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Lonza to host new webinar – “Paper to EBR in nine months: how a strong collaboration leads to project success”
Free Lonza webinar to discuss the benefits of a collaborative approach to implementing an Electronic Batch Record Platform.
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CPhI 2019: Steriline, leader in robotics, presents its new robotic nest filling machine for research lab
Steriline continues to prove itself as an excellent partner for pharmaceutical companies worldwide, from now on also during earlier and more sensitive phases of drugs development.
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UK government invests in global partnership to treat gonorrhoea
The UK government will invest £3.5 million to help develop new antibitoic treatments for gonorrhoea and make them available to low- and middle-income countries.
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FDA proposes three solutions to mitigate drug shortages
The FDA has compiled a report which identifies the root causes of medicine shortages and suggests potential ways to alleviate scarcities.
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Regulatory non-compliance business interruptions
Loss of manufacturing capability as a result of regulatory non-compliance can have a devastating impact on biopharma or medical device manufacturers. In this article, Jenny Yu shares real-life examples from the industry and highlights the downstream effects of these business interruptions.
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The potential of the Indian pharmaceutical industry
According to research from the Indian Pharmaceutical Alliance, the country’s pharma sector has capacity to grow. This article investigates some of the goals, challenges and proposals the report sets out for the industry.
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European Pharmaceutical Review Issue 5 2019
Within this issue is an analysis of the impacts that low temperature can have on protein aggregation, a discussion on maintaining the safety and quality of medicines when delivered using drones and an exploration of chromatographic techniques used to identify impurities in radiopharmaceuticals. Other articles focus on regulatory non-compliance, excipients…
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FDA releases statement on reducing drug shortages
The FDA has announced its support of a drug manufacturer rating system that would allow purchasers to identify which have the most reliable supply, in an effort to reduce shortages.
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New encapsulation technology could improve drug delivery
Encapsulation technology, a simple and efficient technique to coat liquid medication in milliseconds, could improve drug delivery.
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Mutagenic impurities – a JPAG event
The Joint Pharmaceutical Analysis Group held an event in London, discussing the testing of nitrosamine mutagenic impurities in pharmaceutical products and the next steps for manufacturers to take.
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FDA issues warning letter to Torrent Pharmaceuticals
Torrent Pharmaceuticals has received a warning letter from the FDA for violating cGMP regulations at its manufacturing facility in India.
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Pharmaceutical product development within the Fujifilm Group
Custom manufacturing of specialty chemicals and APIs.
