Process Validation: Form-Fill-Seal for Drugs (GUI-0008)

Process Validation: Form-Fill-Seal for Drugs (GUI-0008) This guide is intended to provide drug dosage form manufacturers with guidance on the validation of Form-fill-seal processes and outlines what is expected to be covered by fabricators, packagers/labellers, however, not intended to specify how validation is to be conducted. 2023-02-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyform-fill-seal processesGUI-0008guidance on process-validationdrug dosage formmanufacturers Process Validation: Form-Fill-Seal for Drugs (GUI-0008)HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/form-fill-seal-drugs-0008.html Process Validation: Form-Fill-Seal for Drugs (GUI-0008)HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/bonnes-pratiques-fabrication/validation/formage-remplissage-scellage-medicaments-0008.html

This guide is intended to provide drug dosage form manufacturers with guidance on the validation of Form-fill-seal processes and outlines what is expected to be covered by fabricators, packagers/labellers, however, not intended to specify how validation is to be conducted.

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