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This poses a significant challenge for pharmaceuticalmanufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.
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. AI and future perspectives: a glimpse into tomorrow Figure 2: adapted from Saha, G.
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.
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AI drives automation and optimization that empower pharmaceutical marketers to rapidly scale commercialization-oriented content and activities. The transformative impact of AI on pharmaceutical marketing is significant, with much to consider regarding its promise and how its reshaping the industry.
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While the global trade of fake pharmaceuticals has long been a threat, the COVID-19 pandemic sent the fraudulent market into overdrive. Criminals were able to capitalise on supply chain disruptions, industry regulations being in transition and the urgent global demand for medical products; consequently they thrived.
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.
Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceuticalproduction process. They play a crucial role in assuring the efficacy and safety of products given to patients.
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
The Guidance applies to both product-related and therapeutic-area-related activities. The Guidance applies to all member companies of EFPIA and IFPMA, but also acts as useful guidance for all pharmaceutical companies as to how the authorities will interpret the legislative provisions to social media channels. About the authors.
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.
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. Pharmaceuticalproducts are typically Class C (requiring an ISO 7 cleanroom) and Class D (ISO 8). 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.
Researchers have shown that a newly developed two-chamber setup (TCS) for containment investigations consisting of an emission and a detection chamber may predict highly potent active pharmaceutical ingredient (HPAPI) dustiness in a sealed system at different flow conditions.
These molecules of interest also impacted the pharmaceutical industry, and pharmaceutical companies faced a requirement to rapidly adopt risk mitigation plans to monitor the presence of nitrosamines in drug products. However, this regulatory ban does not impact active pharmaceutical ingredients (APIs).
Single- or mono-temperature incubation is not easy to implement, but it offers efficiency and performance advantages and an opportunity to simplify the process in a pharmaceutical microbiology laboratory. Phase 2 included selection of 32 new strains mainly found in the pharmaceutical industry (see Table 2).
Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceuticalproducts. Pharmaceutical Technology has listed some of the leading contract commercial packaging companies, based on its intel, insights and decades-long experience in the sector.
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.
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.
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. How can these issues be addressed?
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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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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