Out of Specification Advanced Therapy Medicinal Products – Guidance for Healthcare Organisations

Due to the unique nature of cell or tissue-based ATMPs, there are occasions  when the manufactured medicine is not in full compliance with the release specification.  Administration of out-of-specification (OOS) ATMPs is exceptionally permissible from a regulatory perspective. It, however, poses challenges to the NHS. The aim of the Pan UK Pharmacy Working Group for ATMPs in producing this document is to clarify the regulatory perspective regarding OOS ATMPs, and to provide guidance to NHS organisations which are provider sites for ATMPs, about governance in the event of an OOS ATMP being supplied for one of their patients.

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