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Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceuticalmanufacturing, the addition of AI technologies introduce a paradigm shift. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.
Researchers have developed an ultrasensitive analytical method for quantifying nitrite quantity in process water for pharmaceuticalproducts. The authors noted that the observations were contextualised to “illustrate the amounts of nitrosamine that could be formed from process water during API and drug productmanufacture”.
To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. The result is efficient, cost-effective and high-quality (bio)pharmaceuticalproduction.
43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for PharmaceuticalManufacturing. According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies.
Based on the new cost estimates, pharmaceuticalmanufacturers in Finland alone will be required to fund 280816 million of these expenses, The directive , enforced on 1 January 2025, imposes an extended manufacturer responsibility on the removal of micro-pollutants from wastewaters.
Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceuticalproduction facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries.
From the examination of raw materials through the release of the finished packaged product, Quality Control Authorities like Central Drugs Standard Control Organisation in India established under the Drugs & Cosmetics Act, 1940. They play a crucial role in assuring the efficacy and safety of products given to patients.
Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis. Different ISO standards are required depending on the processes and products developed within the environment. Meeting strict standards.
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.
To appreciate the scope of the challenge facing the pharmaceutical market, as well as patients across the globe, we must understand that there are two distinct threats – ‘counterfeit’ and ‘falsified’ medicines. There is also the challenge of falsified medicines – the fake, unauthorised medical products that make their way into the market.
According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceuticalproduct recalls and accounted for 45.3
Processes in pharmaceuticalmanufacturing such as processing, milling, grinding, and mixing, are associated with the generation of dust. The researchers highlighted that the risks of hazard exposure include danger to the health of operators and cross-contaminations during manufacturing.
Applying AI to GVDs Amassing comprehensive productand market-related data, GVDs demonstrate the value of a pharmaceuticalproduct to various stakeholders, including payers, healthcare providers, and regulatory bodies. It leveraged experts input at key points in the process, to assess and validate the work.
Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceuticalmanufacturer in Canada, for an undisclosed sum. The merged entity represents one of the biggest specialist generic injectable operations in Canada with local manufacturing facilities.
Freeze drying is a crucial technique to prolong the shelf life of pharmaceuticalproducts. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.
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. Regulatory body – NMPA : all pharmaceuticalproducts sold in the Chinese market need to be granted market authorization by NMPA.
Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation.
Pharmaceutical wholesalers act as intermediaries between pharmaceuticalmanufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs.
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] However, this regulatory ban does not impact active pharmaceutical ingredients (APIs).
Each strain was selected to take into account: the variability of environmental and human strains in a pharmaceuticalproduction environment strains known for their particular growth conditions, such as growth temperature, invasiveness, growth difficulties, etc (eg, Cladosporium , specific moulds, corynebacteria , Bacillus , etc).
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.
The WHO called on key stakeholders, including regulators, governments and manufacturing facilities, to take immediate and coordinated action. In this instance of contaminated cough syrups, the concern is around an excipient in the product and not the active pharmaceutical ingredient (API).
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. But this results in huge, complex datasets.
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