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

View metadata and access the original English HTML file: Process Validation: Form-Fill-Seal for Drugs (GUI-0008).

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HTML

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file-only

Publisher-reported update

2023-02-27

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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