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However, the knowledge generated using a PAT framework can help to seamlessly transfer these insights to pilot testing and manufacturing operations. The result is efficient, cost-effective and high-quality (bio)pharmaceuticalproduction. In April 2022 both companies were acquired by Bruker.
.” These products are disguised as legitimate branded medicines and it can be difficult for those across the supply chain, as well as patients, to detect counterfeit products from authentic originals. There is also the challenge of falsified medicines – the fake, unauthorised medical products that make their way into the market.
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceuticalmanufacturing site quality rating system, the Quality management maturity (QMM) programme. April 2022.
Libby Amos-Stone, Counsel, acts for life sciences companies in product liability and public law litigation before the UK and EU Courts, and advises clients on the pharmaceutical, medical device, food, cosmetic, and cannabis regulatory framework in the UK and EU.
Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1]
At the start of this year, the World Health Organisation (WHO) said that more than 300 children had died in The Gambia, Indonesia and Uzbekistan in 2022 in deaths linked to contaminated medicine. In this instance of contaminated cough syrups, the concern is around an excipient in the product and not the active pharmaceutical ingredient (API).
A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. What are the top three supply-related challenges facing pharmaceuticalmanufacturers?
In an age of disruption, technology is key to enabling pharmaceuticalmanufacturers monitor, track and control shipments and their processes. Pharmaceutical firms are changing the way they do business; the future winners will be highly automated and digitalised. To learn more, download the paper below. [i]
Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceuticalproducts. From 2017 to 2022, the Chinese market witnessed a growth rate of 5.3%, compared to the average market growth of 6.6%
Implementing PAT in (bio)pharmaceuticalmanufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility. Good Design Practices for GMP Pharmaceutical Facilities.
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