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This is a library of Lhasa's blog articles. 

  • Collaboration Innovation Working together data sharing
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    Anticipating and supporting the needs of our members

    As a member-based organisation, anticipating and supporting the needs of our members is critical. 

    31 July 2020

  • Image for solubility purge best practice blog
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    Lhasa Limited collaborates with industry and regulators to define solubility purge best practice

    Key to the regulatory acceptance of purge arguments is the conservatism within the purge factor scoring system, which for reactivity purge has been demonstrated across a number of publications and is consistently implemented across the pharmaceutical industry through the development of a collective understanding of and how they should be applied.

    Likewise, when volatility purge scoring is relatively simple to understand and apply, particularly using the scoring thresholds originally proposed by Teasdale et al.

    However, through our interactions with Mirabilis users, regulators, and other members of the purge community, it has become increasingly apparent that the same cannot be said of solubility purge scoring. Lhasa have therefore identified the huge value to the community of developing an accepted best practice, incorporating both the application of solubility purge scoring and, where appropriate, provision of a clear justification of the purge factor assigned.

    29 October 2020

  • Lhasa Limited supports the global challenge of nitrosamine impurity assessment
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    Lhasa Limited supports the global challenge of nitrosamine impurity assessment

    The recent discovery of N-nitrosamine (nitrosamine) impurities in several marketed pharmaceuticals has led to a requirement for further investigation into nitrosamine mutagenic and carcinogenic activity. Regulatory requirements mean that marketing authorisation holders for human medicines, containing chemically synthesised active substances, must review their medicines for the possible presence of nitrosamines and test all products at risk. Risk-based approaches to prioritise evaluations and subsequent confirmatory testing may be used. These assessments must be completed by October 2020, generating a significant challenge for the pharmaceutical industry.

    13 July 2020

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