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The EBE is developing a series of Concept Papers

The aim of the Concept Papers is twofold. First, to act as a practical implementation guide for manufacturers, bridging the gap between regulatory guidelines and manufacturing practice and, secondly, to facilitate dialogue and communication with the regulators.

Each Concept Paper will address a specific topic and the current publications include:

 



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  • Downloads

  • Good Manufacturing Practice (GMP) for Advanced Therapies Medicinal Products (ATMP)

    23/11/10

    (541.666kb) >> Download

  • Multi-purpose Use of Plants

    30/04/10

    (776.116kb) >> Download

  • Multi-purpose Use of Plants (cover)

    30/04/10

    (563.073kb) >> Download

  • Comparability

    30/04/10

    (986.171kb) >> Download

  • Comparability (cover).

    30/04/10

    (547.888kb) >> Download

  • Critical Parameters and Continued Process Verification

    30/04/10

    (3823.678kb) >> Download

  • Critical Parameters and Continued Process Verification (cover)

    30/04/10

    (534.677kb) >> Download