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GxP News

  • First-ever MHRA analysis of UK clinical trial applications finds new opportunities to drive medical breakthroughs for patients

    New analysis of the current clinical trial landscape in the UK shows clear opportunities to shape the future of medical research and patient care.

  • FDA Warning Letter: Missing Ongoing Stability Program for Biotech APIs

  • Pharmeuropa: Four Draft Chapters on Elemental Analysis Published for Comment

  • Q&A Document on QP Declaration updated

  • Missing Tests and Altered Records: FDA Warns Chinese OTC Manufacturer

  • GMP Violations by Chinese OTC Manufacturer

  • Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery 

    As with all products, the MHRA will keep its safety under close review.

  • World Health Organization confirms MHRA to continue playing vital role in ensuring the quality of global biological medicines  

    The World Health Organization (WHO) has confirmed the successful redesignation of the Medicines and Healthcare products Regulatory Agency (MHRA)’s Science and Research group as one of its Collaborating Centres for the Standardisation and Evaluation of Biologicals for the next four years.   

  • MHRA Safety Roundup: March 2025

    Summary of the latest safety advice for medicines and medical device users

  • Decision: Triheptanoin in the treatment of long-chain fatty acid oxidation disorders (LC-FAOD)

    Triheptanoin used to treat long-chain fatty acid oxidation disorders (LC-FAOD), a group of rare inherited disorders, in adults and children of all ages.