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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

This poses a significant challenge for pharmaceutical manufacturers, 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.

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Elevating pharmaceutical manufacturing processes with real-time insights

European Pharmaceutical Review

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)pharmaceutical production. Enter the era of benchtop NMR solutions.

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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

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 pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Regulatory Compliance: Ensuring that pharmaceutical products meet all regulatory requirements and guidelines, including safety, efficacy, labelling, and post-marketing surveillance

eMediWrite

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.

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Cleanrooms-on-demand: a more efficient future for pharma?

pharmaphorum

However, with cleanrooms-on-demand representing a feasible and accessible opportunity for those across pharmaceutical manufacturing, 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

Pharma 98
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AI IN PHARMACEUTICAL MARKETING: Optimizing Automation and Expertise

PM360

Applying AI to GVDs Amassing comprehensive productand market-related data, GVDs demonstrate the value of a pharmaceutical product 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.

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Tackling fake pharmaceuticals: an industry united against counterfeit products

European Pharmaceutical Review

.” 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.