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Vacuum Tray Dryer – OQ Protocol
Document ID: OQ-VD-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Operational Qualification Protocol for Vacuum Tray Dryer Objective: To validate the operational performance of the Vacuum Tray Dryer used for low-temperature drying in the production of solid dosage forms.…
NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – OQ Protocol
Document Control Document Number: OQ-001 Revision: 1.0 Date: 2023-10-01 Prepared By: Validation Team Approved By: QA Manager Operational Qualification Protocol for NDDS Process Control System Objective: To validate the NDDS Process Control System (PLC/SCADA) to ensure it meets the specified…
RABS / Isolator (if used) – Deviation Impact Assessment
Deviation Impact Assessment Template Equipment: RABS / Isolator Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Provide a detailed description of the deviation. Classification Classify the deviation (e.g., Major, Minor, Critical). Product/Patient Impact Assess and document…