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Nitrosamine Mitigation: A Path to Regulatory Compliance

PharmaTech

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever.

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor. As such, this “could impact the need for rigorous quality control measures, such as pyrogen testing”.

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What gene therapy manufacturers can gain from collaboration

European Pharmaceutical Review

Challenges in gene therapy manufacturing Photo: courtesy of PTC Therapeutics The biotech industry is facing a bottleneck in product manufacturing, with more than 1,000 gene therapies currently being developed as potential clinical candidates, 1 and not nearly enough capacity in manufacturing facilities to accommodate them.

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” One case of drug contamination from 2021 was highlighted in the paper. Ahmed et al.

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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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RFID: The future of smart labelling?

Pharmaceutical Technology

In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs. In recent times, various global administrators have issued regulatory standards. Why the use of RFID has fluctuated over the past decade?

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LAMP assays to enable rapid and sensitive detection of BCC

European Pharmaceutical Review

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 pharmaceutical product recalls and accounted for 45.3