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Cleaning Validation: Application of Annex 15 European GMP manufacturing on a site forming sterile drugs and non-sterile

Moderator A3P : Isabelle SARFATI
facilitators: Ségolène BILLES - Fareva Amboise & Pierre DEVAUX - Teranga Group / UPS Consultant

This workshop proposes to show the practical application of the 10 chapter of Annex 15 of the European GMPs dedicated to the validation of cleaning at a sterile and non-sterile multiform shaping site. The day should make it possible to correctly interpret the 15 paragraphs of chapter 10 based on the practical guide published by the GIC A3P Validation of the Cleaning. This workshop will take stock of the latest regulatory trends including the calculation of acceptance criteria with the publication of a new guide at the beginning of the 2017 year calling into question the PDE approach for non-highly active products "Questions and answers (EMA / CHMP / CVMP / SWP / 169430 / 2012) "on the implementation of a risk-based approach to the prevention and control of cross-contamination in production

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