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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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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services. This was attributed to their “highly sensitive and specific” testing capabilities.

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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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Leading freeze-drying systems suppliers for the pharmaceutical industry

Pharmaceutical Technology

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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Automation to accelerate biopharma in next decade

European Pharmaceutical Review

Automated solutions, especially those aided by artificial intelligence (AI) , can enhance product safety, the report noted. Pharmaceuticals production lines are challenged by customised dosages and products such as pre-filled syringes. Popularity of injectables has also increased the focus on sterility.

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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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Quality by design with a focus on biosimilars

Pharmaceutical Technology

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines.