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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

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Elevating pharmaceutical manufacturing processes with real-time insights

European Pharmaceutical Review

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)pharmaceutical production. principles.

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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

Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceutical production process. They play a crucial role in assuring the efficacy and safety of products given to patients. A company’s systems transparency may also be shown by such data.

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Getting ahead of regulatory changes around PFAS in pharmaceutical packaging

Clarivate

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).

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Harrow agrees to acquire US rights to Novartis’ ophthalmic products

Pharmaceutical Technology

On concluding the NDA transfer period, Harrow will take over the complete US market operations and commence works to manufacture the products through third parties. Outside of the US region, Novartis will have sole rights to the products.

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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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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. What is the biggest impact of having compromised data when working with regulatory bodies in the pharmaceutical industry?