Procesvalidatierapport


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Zakelijk rapport Nummer Naam Werkwijze Validatierapport bevestiging

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TEM-295 Issue date Process Validation Interim / Final Report (Reference: SOP ) Enter Product Title, Number Strength PRODUCT CODE: WRITTEN BY: REVIEWED BY: Name: Signature: Position: Date: Qualification Status Qualification of enter raw material item description, item code as per protocol enter protocol no has been completed for the following: • enter product name, code and lot no All deviations and additional protocol results for the batch are documented in this interim report.. Table 7.3.2.2: The Actual Tabletting / Encapsulation settings guides used Parameter Enter parameter Enter parameter Enter parameter Enter parameter Enter parameter Dosage Dosage Enter set point / range Enter set point / range Enter set point / range Enter set point / range Enter set point / range Enter set point / range Enter set point / range Enter set point / range Enter set point / range Enter set point / range 7.4 Equipment Used – Validation Status Table 7.4.1: Equipment used in the manufacture and testing of enter product name Process Equipment Step Enter process Enter piece of equipment step Equipment Enter process Enter piece of equipment step Equip..

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