EMA Guideline shared facilities

On setting health exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities is in force as of June 1, 2015.

The method of calculation of an API Permitted Daily Exposure (PDE) is described in Appendix 3 of ICH Q3C (R4) and in appendix 3 of VICH GL. 18.

Socosur Azierta agreement:

  • Identification of “critical effects”.
  • Use of several adjustment factors to account for various uncertainties.

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