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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. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.
Researchers have developed an ultrasensitive analytical method for quantifying nitrite quantity in process water for pharmaceuticalproducts. The post Chromatography analysis for nitrosamine quantitation in pharmaceuticalmanufacturing water appeared first on European Pharmaceutical Review. Kumar et al.
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. Enter the era of benchtop NMR solutions.
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.
43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for PharmaceuticalManufacturing. Specifically, the document covers the development process of glass containers for pharmaceuticalproducts, glass container sampling as well as definition of lots.
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.
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.
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
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.
.” 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.
Processes in pharmaceuticalmanufacturing such as processing, milling, grinding, and mixing, are associated with the generation of dust. The compounds used in the pharmaceuticalproduction are exposed to a wide variety of stresses. Thus, formulation dust containing HPAPIs is a major problem concerning potential exposure.
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.
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.
What are the top three supply-related challenges facing pharmaceuticalmanufacturers? Hayat Biotech’s global supply chain, spanning distribution to 64 countries, entails the involvement of multiple suppliers, distributors, and contract manufacturing organisations. How can these issues be addressed?
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.
However, with cleanrooms-on-demand representing a feasible and accessible opportunity for those across pharmaceuticalmanufacturing, what are the key challenges in adoption and how can we expect the industry to overcome them to reap the rewards on offer? But with a single dedicated cleanroom environment costing around $2.5
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).
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]
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.
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.
In this instance of contaminated cough syrups, the concern is around an excipient in the product and not the active pharmaceutical ingredient (API). It is therefore essential that all components used in the pharmaceuticalmanufacturing process and not just the API must be assessed and tested to full monograph specifications.
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.
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