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Qualified Person Certification and Batch release

All batches of pharmaceutical products require certification by a Qualified Person in accordance with Eudralex volume 4, Annex 16 for clinical and commercial supply of pharmaceutical products within the UK & throughout Europe.The systems and processes in place to govern the batch review process must be effective and robust as well as being efficient and suitable for your companyu2019s operational needs.<br>For more details: https://paulrpalmer.com/service/batch-release-support/

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Qualified Person Certification and Batch release

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  1. Qualified Person (QP) Certification & Batch Release – UK In the UK and Europe, pharmaceutical batch release is a legally mandated process requiring certification by a Qualified Person (QP). Paul R Palmer Limited offers expert QP services to ensure that each batch meets regulatory standards before market release. A QP must hold a UK-issued eligibility certificate, awarded by professional bodies on behalf of the MHRA after rigorous assessment. Their role includes verifying manufacturing and testing processes, ensuring compliance with Good Manufacturing Practice (GMP), and certifying that products are safe and effective. Paul R Palmer brings deep experience in sterile manufacturing and system optimization. The consultancy supports companies with: QP batch certification GMP compliance audits Process improvement for batch review Regulatory training and advisory All batch release activities follow Eudralex Volume 4, Annex 16, ensuring alignment with UK and EU standards. The firm emphasizes efficient, audit-ready systems tailored to operational needs. Whether for clinical or commercial supply, Paul R Palmer Limited helps pharmaceutical companies navigate complex compliance landscapes with confidence and precision. For more details: Location: Amelia House, Crescent Road, Worthing, West Sussex, BN11 1QR Phone: +44(0) 1903 366167 Email: paul@paulrpalmer.com Website: https://paulrpalmer.com/

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