Tag Archive: GIRP Supply Chain Conference

  1. GIRP Supply Chain Conference 2024 – 9th Edition

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    We are pleased to announce that our Director, Kane Edgeworth, will be a featured speaker at the GIRP Supply Chain Conference 2024, taking place from 14th to 15th October 2024 in Lisbon, Portugal..

    Kane will join an expert panel for a session focussing on “Transforming Digital Capabilities in the Temperature-Controlled Supply Chain,” a key theme in the rapidly evolving pharmaceutical and healthcare logistics sector.

    Presenting the possibility of a continuous mapping model vs the traditional methods in a session moderated by Mr John Preston, Director of Regulatory and Development, HDA UK.

    Transforming Digital Capabilities in the Temperature-Controlled Supply Chain.

    Speakers.

    • Mr Kane Edgeworth, Director, Biomap Ltd
    • Mr Alexandre Bosdonnat, Business Development Manager, Lainpharma
    • Ms Anni Svala, Quality Director, Tamro Finland, Vice-President, European Industrial Pharmacist Group
    • Mr Bruno Alves, Vaccines, Immunization, and Biological Products Unit, Directorate General of Health (DGS

    We look forward to Kane sharing his insights on how innovative digital tools and processes can enhance the efficiency and security of temperature-controlled supply chains.

    For more information and to see the full conference agenda, visit the official: https://scc.girp.eu/

     

  2. MHRA Qualification & Validation: COVID-19

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    MHRA publishes GDP flexibilities for Qualification & Validation work during COVID-19 outbreak

    The MHRA has published guidance concerning some flexibilities in Good Distribution Practice during the COVID-19 pandemic. This includes some exceptional allowances within the supply chain, transportation, and storage. One particular area is regarding the benefit of retrospective Qualification and Validation work but must be carefully recorded and supported by a risk assessment. 

    “Storage and distribution equipment may be used with limited qualification and validation to allow equipment to be used as soon as possible. This should be supported by a risk assessment and additional mitigating measures where necessary. Remaining qualification and validation work should be completed retrospectively, with delay minimised as much as possible”

    How can Biomap help?

    Biomap can support the Risk Assessment process if projects need to be postponed, and retrospective validation will be carried out later on due to the pandemic. We can assist with collating the required information and presenting it in the correct formats. For example:

    • Assessment of equipment/facility being validated
    • Review of Change Control
    • Validation due dates & required works
    • Historical works and performance
    • Summary of actions
    • Drafting Risk Assessment

    Alternatively, Biomap can also offer a range of remote qualification kits for clients to continue to execute their validation schedules as planned (without the need of an engineer on site)  https://biomap.co.uk/covid19-remote-validation-service/  

    Contact us for further information – info@biomap.co.uk

    See full MHRA release: “Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak”: https://bit.ly/2YBuNch