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08:46 Feb 11, 2020 |
French to English translations [PRO] Medical - Medical: Pharmaceuticals / Inpection of Pharma establishment | |||||||
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| Selected response from: Drmanu49 France Local time: 07:59 | ||||||
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Summary of answers provided | ||||
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4 | OGS on going stability |
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3 | general safety requirement |
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general safety requirement Explanation: Since you mention a "production sheet", this could be a form to comply with the "Obligation générale de sécurité" https://www.economie.gouv.fr/dgccrf/Publications/Vie-pratique/Fiches-pratiques/obligation-generale-de-securite |
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OGS on going stability Explanation: En 2013, il a été déclaré 37 résultats d’analyse hors des spécifications définies par le titulaire de l’autorisation de mise sur le marché dans le cadre du programme de suivi continu de la stabilité des médicaments fabriqués et mis sur le marché (OGS on going stability). |
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